Surgical staples and stapling instruments

ABSTRACT

A staple having a crown and first and second deformable members extending from the crown. In at least one embodiment, the staple further includes a base connecting the first and second deformable members where the base is not entirely co-planar with the first and second deformable members. In these embodiments, the crown can be overmolded onto, or attached to, the base and provide a larger and/or more stable tissue-contacting surface for supporting the tissue captured by the staple. As a result, the possibility of the staple being pulled through the tissue and/or the tissue tearing within or around the staple is reduced.

CROSS REFERENCE TO RELATED APPLICATIONS

The subject application is related to eleven co-pending andcommonly-owned applications filed on even date herewith, the disclosureof each is hereby incorporated by reference in their entirety, theseeleven applications being respectively entitled:

(1) Surgical Stapling Instruments Having Flexible Channel and AnvilFeatures For Adjustable Staple Heights to Frederick E. Shelton, IV,Jerome R. Morgan, Michael A. Murray, Richard W. Timm, James T. Spivey,James W. Voegele, Leslie M. Fugikawa, and Eugene L. Timperman (K&LNGDocket No. 060500CIP1/END5706USCIP1);

(2) Surgical Stapling Instruments With Collapsible Features ForControlling Staple Height to Frederick E. Shelton, IV, Jeffrey S.Swayze, Leslie M. Fugikawa, and Eugene L. Timperman (K&LNG Docket No.060500CIP2/END5706USCIP2);

(3) Surgical Cutting and Stapling Instrument With Self Adjusting Anvilto Frederick E. Shelton, IV and Joshua Uth (K&LNG Docket No.060492/END5962USNP);

(4) Surgical Cutting and Stapling Device With Closure Apparatus ForLimiting Maximum Tissue Compression Force to Frederick E. Shelton, IVand Jeffrey S. Swayze (K&LNG Docket No. 060493/END5963USNP);

(5) Surgical Stapling Instrument With Mechanical Mechanism For LimitingMaximum Tissue Compression to Todd Phillip Omaits, Bennie Thompson,Frederick E. Shelton, IV and Eugene L. Timperman (K&LNG Docket No.060490/END5960USNP);

(6) Surgical Stapling Instruments and Staples to Christopher J. Hess,William B. Weisenburgh, II, Jerome R. Morgan, James W. Voegele,Frederick E. Shelton, IV and Joshua Uth (K&LNG Docket No.060494/END5965USNP);

(7) Surgical Staples Having Dissolvable, Bioabsorbable orBiofragmentable Portions and Stapling Instruments For Deploying The Sameto Christopher J. Hess, Michael A. Murray, Jerome R. Morgan, James W.Voegele, Robert Gill, and Michael Clem (K&LNG Docket No.060495/END5966USNP);

(8) Connected Surgical Staples and Stapling Instruments For DeployingThe Same to Christopher J. Hess, William B. Weisenburgh, II, Jerome R.Morgan, Frederick E. Shelton, IV, Leslie M. Fugikawa, and Eugene L.Timperman (K&LNG Docket No. 060499/END5970USNP);

(9) Surgical Staples Having Attached Drivers and Stapling InstrumentsFor Deploying the Same to Christopher J. Hess, Jerome R. Morgan, MichaelClem, Frederick E. Shelton, IV, and William B. Weisenburgh, II (K&LNGDocket No. 060496/END5967USNP);

(10) Surgical Stapling Instrument With Mechanical Indicator To ShowLevels of Tissue Compression to Todd. P. Omaits, Bennie Thompson,Frederick E. Shelton, IV, and Eugene L. Timperman (K&LNG Docket No.060491/END5961USNP); and

(11) Surgical Staples Having Compressible or Crushable Members ForSecuring Tissue Therein and Stapling Instruments For Deploying The Sameto Christopher J. Hess, Jerome R. Morgan, William B. Weisenburgh, II,James W. Voegele, Carl Shurtleff, Mark Ortiz, Michael Stokes, FrederickE. Shelton, IV, and Jeffrey S. Swayze (K&LNG Docket No.060497/END5968USNP).

FIELD OF THE INVENTION

The present invention generally relates to endoscopic and open surgicalinstrumentation and, more particularly, to surgical staples and staplersincluding, but not limited to, open surgical stapling devices,laparoscopic surgical stapling devices, endoscopic and intralumenalsurgical stapling devices.

BACKGROUND

Endoscopic and laparoscopic surgical instruments are often preferredover traditional open surgical devices since a smaller incision tends toreduce the post-operative recovery time and complications. The use oflaparoscopic and endoscopic surgical procedures has been relativelypopular and has provided additional incentive to develop the proceduresfurther. In laparoscopic procedures, surgery is performed in theinterior of the abdomen through a small incision. Similarly, inendoscopic procedures, surgery is performed in any hollow viscus of thebody through narrow endoscopic tubes inserted through small entrancewounds in the skin.

Laparoscopic and endoscopic procedures generally require that thesurgical region be insufflated. Accordingly, any instrumentationinserted into the body must be sealed to ensure that gases do not enteror exit the body through the incision. Moreover, laparoscopic andendoscopic procedures often require the surgeon to act on organs,tissues and/or vessels far removed from the incision. Thus, instrumentsused in such procedures are typically long and narrow while beingfunctionally controllable from a proximal end of the instrument.

Significant development has gone into a range of endoscopic surgicalinstruments that are suitable for precise placement of a distal endeffector at a desired surgical site through a cannula of a trocar. Thesedistal end effectors engage the tissue in a number of ways to achieve adiagnostic or therapeutic effect (e.g., endocutter, grasper, cutter,staplers, clip applier, access device, drug/gene therapy deliverydevice, and energy device using ultrasound, RF, laser, etc.).

Known surgical staplers include an end effector that simultaneouslymakes a longitudinal incision in tissue and applies lines of staples onopposing sides of the incision. The end effector includes a pair ofcooperating jaw members that, if the instrument is intended forendoscopic or laparoscopic applications, are capable of passing througha cannula passageway. One of the jaw members receives a staple cartridgehaving at least two laterally spaced rows of staples. The other jawmember defines an anvil having staple-forming pockets aligned with therows of staples in the cartridge. The instrument includes a plurality ofreciprocating wedges which, when driven distally, pass through openingsin the staple cartridge and engage drivers supporting the staples toeffect the firing of the staples toward the anvil.

Recently, an improved “E-beam” firing bar was described for a surgicalstapling and severing instrument that advantageously included a top pinthat slides within an internal slot formed in the upper jaw (anvil) andhas a middle pin and bottom foot that slides on opposite sides of alower jaw of an end effector, or more particularly a staple applyingassembly. Distal to the middle pin, a contacting surface actuates astaple cartridge held within an elongate staple channel that forms thelower jaw. Between the contacting surface and the top pin, a cuttingsurface, or knife, severs tissue clamped between the anvil and thestaple cartridge of the lower jaw. Since both jaws are thus engaged bythe E-beam, the E-beam maintains a desired spacing between the jaws toensure proper staple formation. Thus, if a lesser amount of tissue isclamped, the E-beam holds up the anvil to ensure sufficient spacing forthe staples to properly form against an undersurface of the anvil. Inaddition, if a greater amount of tissue is clamped, the E-beam drawsdown the anvil to ensure that the spacing does not exceed the length ofthe staple such that ends of each staple are not sufficiently bent toachieve a desired degree of retention. Such an E-beam firing bar isdescribed in U.S. patent application Ser. No. 10/443,617, entitled“Surgical Stapling Instrument Incorporating an E-Beam Firing Mechanism”,filed on May 20, 2003, now U.S. Pat. No. 6,978,921, issued Dec. 27,2005, the disclosure of which is hereby incorporated by reference in itsentirety.

While an E-beam firing bar has many advantages for a surgical staplingand severing instrument, often it is desirable to sever and stapletissue of various thicknesses. A thin layer of tissue may result instaples that only form loosely, perhaps requiring the need forbolstering material. A thick layer of tissue may result in formedstaples that exert a strong compressive force on the captured tissue,perhaps resulting in necrosis, bleeding or poor stapleformation/retention. Rather than limiting the range of tissuethicknesses that are appropriate for a given surgical stapling andsevering instrument, it would be desirable to accommodate a wider rangeof tissue thickness with the same surgical stapling and severinginstrument.

Consequently, a significant need exists for an improved surgicalstapling and severing instrument that incorporates a staple applyingassembly (end effector) that adjusts to the amount of tissue that isclamped.

In addition, the staple drivers that are commonly employed in existingstaple applying assemblies are traditionally made as stiff as possibleto assure proper “B” form staple height. Because of this stiffconstruction, these drivers do not provide any flexibility for adjustingthe formed height of the staple to a particular thickness of tissueclamped within the assembly.

Thus, another significant need exists for staple drivers that are ableto facilitate the adjustment of the formed height of the staples inresponse to variations in tissue thickness.

In various types of encocutter arrangements, the anvil is opened andclosed by axially actuating a closure tube assembly that serves tointerface with closure features on the proximal end of the anvil. Theanvil is commonly formed with trunnions that are received in somewhatelongated slots in the proximal end of the channel. The trunnions serveto pivotally support the staple cartridge and permit the anvil to moveinto axial alignment while pivoting to a closed position. Unfortunately,however, this arrangement lacks means for limiting or adjusting theamount of clamping forces applied to the anvil during the clampingprocess. Thus, the same amount of clamping forces generated by theclosure tube assembly are applied to the anvil regardless of thethickness of the tissue to be clamped therein. Such arrangement canresult in thinner tissues being over clamped which could lead toexcessive bleeding and possibly damage or even destroy the tissue.

Thus, there is another need for a closure system that includes means forlimiting or adjusting the amount of closure forces applied to the anvilbased on the thickness of the tissue to be clamped between the anvil andthe staple cartridge.

In certain types of surgical procedures the use of surgical staples hasbecome the preferred method of joining tissue, and, specially configuredsurgical staplers have been developed for these applications. Forexample, intra-luminal or circular staplers have been developed for usein a surgical procedure known as an anastomosis. Circular staplersuseful to perform an anastomosis are disclosed, for example, in U.S.Pat. No. 5,104,025 and U.S. Pat. No. 5,309,927 which are each hereinincorporated by reference.

An anastomosis is a surgical procedure wherein sections of intestine arejoined together after a connecting section has been excised. Theprocedure requires joining the ends of two tubular sections together toform a continuous tubular pathway. Previously, this surgical procedurewas a laborious and time consuming operation. The surgeon had toprecisely cut and align the ends of the intestine and maintain thealignment while joining the ends with numerous suture stitches. Thedevelopment of circular staplers has greatly simplified the anastomosisprocedure and also decreased the time required to perform ananastomosis.

In general, a conventional circular stapler typically consists of anelongated shaft having a proximal actuating mechanism and a distalstapling mechanism mounted to the shaft. The distal stapling mechanismtypically consists of a fixed stapling cartridge containing a pluralityof staples configured in a concentric circular array. A round cuttingknife is concentrically mounted in the cartridge interior to thestaples. The knife is moveable in an axial, distal direction. Extendingaxially from the center of the cartridge is a trocar shaft. The trocarshaft is moveable, axially, with respect to the cartridge and elongatedshaft. An anvil member is mounted to the trocar shaft. The anvil memberhas a conventional staple anvil mounted to it for forming the ends ofthe staples. The distance between the distal face of the staplecartridge and the staple anvil is controlled by an adjustment mechanismmounted to the proximal end of the stapler shaft. Tissue containedbetween the staple cartridge and the staple anvil is simultaneouslystapled and cut when the actuating mechanism is engaged by the surgeon.

When performing an anastomosis using a circular stapler, typically, theintestine is stapled using a conventional surgical stapler with doublerows of staples being emplaced on either side of a target section (i.e.,specimen) of intestine. The target section is typically simultaneouslycut as the section is stapled. Next, after removing the specimen, thesurgeon typically inserts the anvil into the proximal end of the lumen,proximal of the staple line. This is done by inserting the anvil headinto an entry port cut into the proximal lumen by the surgeon. Onoccasion, the anvil can be placed transanally, by placing the anvil headon the distal end of the stapler and inserting the instrument throughthe rectum. Typically the distal end of the stapler is insertedtransanally. The surgeon then ties the proximal end of the intestine tothe anvil shaft using a suture or other conventional tying device. Next,the surgeon cuts excess tissue adjacent to the tie and the surgeonattaches the anvil to the trocar shaft of the stapler. The surgeon thencloses the gap between the anvil and cartridge, thereby engaging theproximal and distal ends of the intestine in the gap. The surgeon nextactuates the stapler causing several rows of staples to be driventhrough both ends of the intestine and formed, thereby joining the endsand forming a tubular pathway. Simultaneously, as the staples are drivenand formed, a concentric circular blade is driven through the intestinaltissue ends, cutting the ends adjacent to the inner row of staples. Thesurgeon then withdraws the stapler from the intestine and theanastomosis is complete.

During the stapling process, however, the surgeon must be careful not toover compress the material that is being stapled to avoid killing ordetrimentally damaging that tissue. While some prior staplers are fittedwith an indicator mechanism for providing the surgeon with someindication of the spacing between the anvil and the staple cartridge, itis desirable for the stapler to include a mechanism that provides ameans for avoiding over compression of the tissue.

SUMMARY

The present invention includes, in various embodiments, a staple havinga crown and first and second deformable members extending from thecrown. In at least one embodiment, the staple further includes a baseconnecting the first and second deformable members where the base is notentirely co-planar with the first and second deformable members. Inthese embodiments, the crown can be overmolded onto, or attached to, thebase and provide a larger and/or more stable tissue-contacting surfacefor supporting the tissue captured by the staple. As a result, thepossibility of the staple being pulled through the tissue and/or thetissue tearing within or around the staple is reduced.

BRIEF DESCRIPTION OF THE FIGURES

The accompanying drawings, which are incorporated in and constitute apart of this specification, illustrate embodiments of the invention,and, together with the general description of the invention given above,and the detailed description of the embodiments given below, serve toexplain the principles of the present invention.

FIG. 1 is a left side view in elevation of a surgical stapling andsevering instrument with an open end effector (staple applying assembly)with a shaft partially cut away to expose a firing member of a proximalfiring rod and distal firing bar guided by a frame ground andencompassed by a closure sleeve.

FIG. 2 is a left side view of a closed end effector (staple applyingassembly) with a retracted force adjusted height firing bar consistentwith the present invention of the surgical stapling and severinginstrument of FIG. 1 taken in longitudinal vertical cross section alonglines 2-2.

FIG. 3 is a left isometric view of the force adjusted (compliant) heightfiring bar of FIG. 2.

FIG. 4 is a left side view of a distal portion (“E-beam”) of a firstversion of the force adjusted height firing bar of FIG. 2 havinghorizontal slits formed respectively between the top pin and cuttingsurface and between the middle pin and the cutting surface to enhancevertical flexure.

FIG. 5 is a lower left isometric view of a distal portion (“E-beam”) ofa second version of the force adjusted firing bar of FIG. 2 having arelieved lower area of an upper pin to enhance vertical flexure.

FIG. 6 is a front view in elevation of an upper portion of the E-beam ofFIG. 5 taken in vertical and transverse cross section through the upperpin along lines 6-6.

FIG. 7 is a front view of an upper portion of a third version of theE-beam of FIG. 5 taken in vertical and transverse cross section alonglines 6-6 but further including relieved upper root attachments of thetop pin for enhanced vertical flexure.

FIG. 8 is a front view of an upper portion of a fourth version of theE-beam of FIG. 5 taken in vertical and transverse cross section alonglines 6-6 but including a resilient inner vertical laminate layerinstead of a relieved undersurface of the top pin for enhanced verticalflexure.

FIG. 9 is a front view of an upper portion of a fifth version of theE-beam of FIG. 5 taken in vertical and transverse cross section alonglines 6-6 but including an upper pin formed of a resilient materialinstead of a relieved undersurface of the upper pin for enhancedvertical flexure.

FIG. 10 is an upper left isometric view of a distal portion (“E-beam”)of a sixth version of the force adjusted firing bar of FIG. 2 havingresilient material upon a bottom foot to enhance vertical flexure.

FIG. 11 is a front view in elevation taken in vertical and transversecross section through the padded lower foot of the end effector (stapleapplying assembly) of the surgical stapling and severing instrument ofFIG. 1.

FIG. 12 is a left view in elevation of a distal portion (“E-beam”) of aseventh version of the force adjusted firing bar of FIG. 2 having aproximally and upwardly extended spring arm attached to a lower foot toenhance vertical flexure.

FIG. 13 is a left top isometric view of a distal portion (“E-beam”) ofan eighth version of the force adjusted firing bar of FIG. 2 having aspring washer encompassing a lower foot to enhance vertical flexure.

FIG. 14 is a cross-sectional end view of another staple applyingassembly or end effector of the present invention in a clamped or closedposition.

FIG. 15 is a partial perspective view of the staple applying assembly ofFIG. 14 with some of the elements thereof shown in cross-section.

FIG. 16 is a cross-sectional end view of another staple applyingassembly or end effector of the present invention in a clamped or closedposition.

FIG. 17 is a partial perspective view of the staple applying assembly ofFIG. 16 with some of the elements thereof shown in cross-section.

FIG. 18 is a partial perspective of a staple applying assembly of thepresent invention clamping a piece of tissue that has been partially cutand stapled.

FIG. 19 is a bottom view of an anvil embodiment of the presentinvention;

FIG. 20 is a longitudinal cross-sectional view of a staple applyingassembly employing the anvil embodiment depicted in FIG. 19.

FIG. 21 is a cross-sectional end view of the staple applying assembly ofFIG. 20 taken along line 21-21 in FIG. 20, with some elements shown insolid form for clarity.

FIG. 22 is another longitudinal cross-sectional view of the stapleapplying assembly of FIGS. 20 and 21 clamping a piece of tissue therein,wherein the tissue has varying cross-sectional thicknesses.

FIG. 23 is another partial longitudinal cross-sectional view of thestaple applying assembly of FIGS. 20-22 clamping another piece of tissuetherein.

FIG. 24 is another partial longitudinal cross-sectional of the stapleapplying assembly of FIGS. 20-23 clamping another piece of tissuetherein.

FIG. 25 is an end cross-sectional view of another staple applyingassembly of the present invention in a clamped position.

FIG. 26 is longitudinal cross-sectional view of another staple applyingassembly of the present invention.

FIG. 27 is a cross-sectional view of a portion of another stapleapplying assembly of the present invention with a piece of tissueclamped and stapled therein.

FIG. 28 is a top view of a portion of a biasing plate embodiment of thepresent invention.

FIG. 29 is a cross-sectional view of a portion of the biasing plate ofFIG. 28 taken along line 29-29 in FIG. 28.

FIG. 30 is an end cross-sectional view of the staple applying assemblyof FIG. 27 with some elements shown in solid form for clarity.

FIG. 30A is an end cross-sectional view of another staple applyingassembly of the present invention with some elements shown in solid formfor clarity.

FIG. 31 is a longitudinal cross-sectional view of the staple applyingassembly of FIGS. 27 and 30 with tissue clamped and stapled therein.

FIG. 32 is another longitudinal cross-sectional view of the stapleapplying assembly of FIG. 31 with another portion of tissue clamped andstapled therein.

FIG. 33 is another longitudinal cross-sectional view of the stapleapplying assembly of FIGS. 30-32 fluidically coupled to a fluidreservoir supported by a handle assembly of various embodiments of thepresent invention.

FIG. 34 is a longitudinal cross-sectional view of a staple applyingassembly of other embodiments of the present invention wherein tissue ofvarying thickness is clamped therein.

FIG. 35 is an enlarged cross-sectional view of a portion of the stapleapplying assembly of FIG. 34.

FIG. 36 is an exploded perspective view of a collapsible staple driverembodiment of the present invention in a first (uncollapsed) position.

FIG. 37 is a cross-sectional view of the collapsible staple driverembodiment of FIG. 36.

FIG. 38 is an exploded perspective view of another collapsible stapledriver embodiment of the present invention in a first (uncollapsed)position.

FIG. 39 is a cross-sectional view of the collapsible staple driverembodiment of FIG. 38.

FIG. 40 is a perspective view of another collapsible staple driverembodiment of the present invention.

FIG. 41 is an exploded perspective view of the collapsible staple driverembodiment of FIG. 40.

FIG. 42 is a cross-sectional view of the collapsible staple driverembodiment of FIGS. 40 and 41 in a first (uncollapsed) position.

FIG. 43 is another cross-sectional view of the collapsible staple driverembodiment of FIGS. 40-42 after compression forces have been appliedthereto.

FIG. 44 is an exploded perspective view of another collapsible stapledriver-embodiment of the present invention.

FIG. 45 is a cross-sectional view of the collapsible staple driverembodiment of FIG. 44 in a first (uncollapsed) position.

FIG. 46 is an exploded perspective view of the collapsible staple driverembodiment of FIGS. 44 and 45 with some of the elements thereof shown incross-section.

FIG. 47 is an exploded front view of another collapsible staple driverembodiment of the present invention.

FIG. 48 is another front view of the collapsible staple driver of FIG.47 in a first (uncollapsed) position.

FIG. 49 is another front view of the staple driver of FIGS. 47 and 48after is has been compressed to a fully collapsed position.

FIG. 50 is an exploded assembly view of another collapsible stapledriver embodiment of the present invention.

FIG. 51 is an exploded front view of the collapsible staple driverembodiment of FIG. 50.

FIG. 52 is another front view of the collapsible staple driverembodiment of FIGS. 50 and 51 after being compressed into a fullycollapsed position.

FIG. 53 is a perspective view of another collapsible staple driverembodiment of the present invention;

FIG. 54 is a side elevational view of the collapsible staple driver ofFIG. 53 in a first (uncollapsed) position.

FIG. 55 is another side elevational view of the collapsible stapledriver of FIGS. 53 and 54 after being compressed to a fully collapsedposition.

FIG. 56 is a perspective view of a surgical cutting and stapleinstrument of various embodiments of the present invention.

FIG. 57 is an exploded assembly view of an end effector and elongateshaft assembly of various embodiments of the present invention.

FIG. 58 is an exploded assembly view of a handle assembly and closureshuttle arrangements of various embodiments of the present invention,with the firing system components omitted for clarity.

FIG. 59 is a cross-sectional side view of the handle assembly depictedin FIG. 58 with the closure trigger thereof in a locked position.

FIG. 60 is a left side exploded assembly view of a closure shuttle andclosure tube assembly of various embodiments of the present invention.

FIG. 61 is a right side exploded assembly view of a closure shuttle andclosure tube assembly of various embodiments of the present invention.

FIG. 62 is a partially enlarged view of a distal end of a closure tubeassembly interacting with a partially closed anvil with some of thecomponents shown in cross-section for clarity.

FIG. 63 is another partially enlarged view of the closure tube and anvilof FIG. 62 with the anvil illustrated in a fully closed position andsome elements shown in cross-section for clarity.

FIG. 64 is a partial perspective view of a closure tube assembly andanvil of various embodiments of the present invention.

FIG. 65 is a partial perspective view of another closure tube assemblyand anvil of various embodiments of the present invention.

FIG. 66 is a partial perspective view of another closure tube assemblyand anvil of various embodiments of the present invention with the anvilin a fully closed position.

FIG. 67 is cross-sectional end view of the closure tube and anvilarrangement of FIG. 66 with the elongate channel omitted for clarity.

FIG. 68 is a partially enlarged view of a closure tube and anvilarrangement of other various embodiments of the present invention withthe anvil in a partially closed position.

FIG. 69 is another partially enlarged view of the closure tube and anvilarrangement of FIG. 68 with the anvil in a fully closed position.

FIG. 70 is a cross-sectional view of another endocutter embodiment ofthe present invention with the anvil thereof in an open position andsome components shown in solid form for clarity.

FIG. 71 is another cross-sectional view of the endocutter embodiment ofFIG. 70 with the anvil in a fully closed position and some componentsshown in solid form for clarity.

FIG. 72 is an enlarged cross-sectional view of a portion of the anviland the closure tube assembly of the embodiments depicted in FIGS. 70and 71 with the anvil in its fully closed position.

FIG. 73 is another cross-sectional view of the endocutter embodiment ofFIG. 70 with the anvil in a maximum clamping position with somecomponents shown in solid form for clarity.

FIG. 74 is an enlarged cross-sectional view of a portion of the anviland the closure tube assembly of the embodiments depicted in FIG. 73with the anvil in its maximum clamping position.

FIG. 75 is an enlarged cross-sectional view of a portion of theendocutter depicted in FIGS. 70-74 clamping a thin piece of tissue.

FIG. 76 is another enlarged cross-sectional view of a portion of theendocutter depicted in FIGS. 70-75 clamping a thicker piece of tissue.

FIG. 77 is a perspective view of another stapling instrument of variousembodiments of the present invention.

FIG. 78 is an exploded perspective assembly view of an anvil and headarrangement that may be employed with various stapler embodiments of thetype depicted in FIG. 77.

FIG. 79 is an exploded perspective assembly view of a shaft and triggerassembly that may be employed with various embodiments of the staplerdepicted in FIG. 77.

FIG. 80 is a partial cross-sectional view of a shaft assembly and headassembly embodiment of the present invention with the anvil attached tothe shaft assembly.

FIG. 81 is a cross-sectional view of the handle assembly and closureknob assembly of various embodiments of the present invention.

FIG. 82 is a perspective view of the shaft assembly, trigger assembly,staple driver, anvil and closure knob assembly with the handle housing,head casing and outer tubular shroud removed therefrom.

FIG. 83 is a cross-sectional view of a knob assembly embodiment of thepresent invention.

FIG. 84 is a cross-sectional view of the knob assembly of FIG. 83 takenalong line 84-84 in FIG. 83.

FIG. 85 is a partial cross-sectional view of a stapler embodiment of thepresent invention inserted into separated portions of intestine.

FIG. 86 is another cross-sectional view of the staple and intestinearrangement of FIG. 85 with the proximal and distal ends of theintestine being sutured around the anvil shaft.

FIG. 87 is another cross-sectional view of the stapler and intestinearrangement of FIGS. 85 and 86 with the anvil retracted to a fullycompressed position and prior to firing the stapler.

FIG. 88 is another cross-sectional view of the stapler and intestinearrangement of FIGS. 85-87 after the staples have been fired and theknife has severed the portions of sutured intestine.

FIG. 89 is a perspective view of another stapler embodiment of thepresent invention.

FIG. 90 is partial cross-sectional view of a portion of the stapler ofFIG. 89.

FIG. 91 is cross-sectional view of a closure actuator that may beemployed with the stapler of FIGS. 89 and 90.

FIG. 92 is a cross-sectional view of the closure actuator of FIG. 91taken along line 92-92 in FIG. 91.

FIG. 93 is a cross-sectional view of a portion of the stapler of FIGS.89-92 inserted in a portion of an intestine with the stapler anvilretracted to a fully compressed position and prior to firing thestapler.

FIG. 94 is a graph illustrating the relationship between a compressionforce and resistive load generated by a variable force generator thatmay be used in connection with various embodiments of the presentinvention.

FIG. 95 is another view of the closure actuator of FIGS. 91 and 92.

FIG. 96 is a side view of a surgical staple in an undeployed shape inaccordance with an embodiment of the present invention;

FIG. 97 is a side view of the staple of FIG. 96 in a first deformedshape;

FIG. 98 is a side view of the staple of FIG. 96 in a second deformedshape;

FIG. 99 is a side view of the staple of FIG. 96 in a third deformedshape;

FIG. 100 is a top view of the staple of FIG. 99;

FIG. 101 is a perspective view of the staple of FIG. 96;

FIG. 102 is a perspective view of the staple of FIG. 97;

FIG. 103 is a perspective view of the staple of FIG. 98;

FIG. 104 is a perspective view of the staple of FIG. 99;

FIG. 105 is a partial cross-sectional view of a surgical stapler, andsurgical staples illustrated in various deformed shapes in accordancewith an embodiment of the present invention;

FIG. 106 is a side view of a surgical staple in accordance with analternative embodiment of the present invention;

FIG. 107 is a perspective view of the staple of FIG. 106;

FIG. 108 is a side view of a staple in accordance with an alternativeembodiment of the present invention;

FIG. 109 is a top view of the staple of FIG. 108;

FIG. 110 is a side view of the staple of FIG. 108 in a deformed shape;

FIG. 111 is a side view of a staple in accordance with an alternativeembodiment of the present invention;

FIG. 112 is a side view of a staple in accordance with an alternativeembodiment of the present invention;

FIG. 113 is a side view of a surgical staple in accordance with anembodiment of the present invention including a crushable member;

FIG. 114 is a side view of the staple of FIG. 113 in a deformed shape;

FIG. 115 is a side view of a surgical staple in accordance with anembodiment of the present invention including a spring having a firstelastic member and a second elastic member;

FIG. 116 is a top view of the staple of FIG. 115;

FIG. 117 is a side view of a surgical staple in accordance with anembodiment of the present invention including a cantilever spring;

FIG. 118 is a top view of the staple of FIG. 117;

FIG. 119 is a side view of a surgical staple in accordance with anembodiment of the present invention including a spring;

FIG. 120 is a side view of the staple of FIG. 119 in a deformed shape;

FIG. 121 is a top view of the staple of FIG. 120;

FIG. 122 is a perspective view of first and second deformable members ofa staple in accordance with an embodiment of the present invention;

FIG. 123 is a perspective view of a dissolvable, or bioabsorbable,material overmolded onto the deformable members of FIG. 122;

FIG. 124 is a perspective view of the staple of FIG. 123 in a deformedshape;

FIG. 125 is a perspective view of the staple of FIG. 124 where a portionof the dissolvable material has been dissolved and the first and seconddeformable members have moved relative to one another;

FIG. 126 is a perspective view of the staple of FIG. 125 after thedissolvable material has completely dissolved;

FIG. 127 is a partial cross-sectional view of a surgical stapler havingan anvil, and a staple cartridge for removably storing staples inaccordance with an embodiment of the present invention;

FIG. 128 is a partial cross-sectional view of the stapler of FIG. 127illustrating several staples in various deformed shapes;

FIG. 129 is a partial cross-sectional view of the stapler of FIG. 127taken along line 129-129 in FIG. 127;

FIG. 129A is a detail view of a staple in FIG. 129;

FIG. 130 is a detail view of the staple of FIG. 129A in a first deformedshape;

FIG. 131 is a detail view of the staple of FIG. 129A in a seconddeformed shape;

FIG. 132 is a side view of a staple in accordance with an alternativeembodiment of the present invention having two materials overmolded ontothe deformable members;

FIG. 133 is a detail view of a staple in accordance with an alternativeembodiment of the present invention;

FIG. 134 is a detail view of a staple in accordance with an alternativeembodiment of the present invention;

FIG. 135 is a perspective view of staples in accordance with anembodiment of the present invention;

FIG. 136 is a top view of a staple cartridge configured to accommodatethe staples of FIG. 135;

FIG. 137 is a detail view of the staple cartridge of FIG. 136;

FIG. 138 is a second detail view of the staple cartridge of FIG. 136;and

FIG. 139 is a cross-sectional view of the staple cartridge of FIG. 136having the staples of FIG. 135 therein.

FIG. 140 is a perspective view of staples and a staple cartridge of astapler in accordance with an embodiment of the present invention;

FIG. 141 is a detail view of the staple cartridge of FIG. 140;

FIG. 142 is a perspective view of a strip of the staples of FIG. 140;

FIG. 143 is a detail view of the staples of FIG. 142;

FIG. 144 is a side cross-sectional view of the staples and staplecartridge of FIG. 140;

FIG. 145 is a perspective view of a strip of staples in accordance withan alternative embodiment of the present invention;

FIG. 146 is a detail view of the staples of FIG. 145;

FIG. 147 is a side cross-sectional view of a stapler deploying thestaples of FIG. 145;

FIG. 148 is a perspective view of a strip of staples in accordance withan alternative embodiment of the present invention;

FIG. 149 is a detail view of the staples of FIG. 148;

FIG. 150 is a side cross-sectional view of a stapler deploying thestaples of FIG. 149;

FIG. 151 is a perspective view of a strip of staples in accordance withan alternative embodiment of the present invention;

FIG. 152 is a view of the staple strip of FIG. 151 stored within astaple cartridge;

FIG. 153 is a cross-sectional view of the staple cartridge of FIG. 152taken along line 153-153 in FIG. 152;

FIG. 154 is a cross-sectional view of the staple cartridge of FIG. 152taken along line 154-154 in FIG. 153;

FIG. 155 is a cross-sectional perspective view of the staple cartridgeof FIG. 152 with staples positioned in a first position;

FIG. 156 is a cross-sectional perspective view of the staple cartridgeof FIG. 152 with the staples positioned in a second position;

FIG. 157 is an additional cross-sectional perspective view of the staplecartridge of FIG. 152;

FIG. 158 is a perspective view of staples in accordance with anembodiment of the present invention connected in a “puck” configuration;

FIG. 159 is a bottom view of a staple cartridge in accordance with analternative embodiment of the present invention configured to receivethe staples of FIG. 158;

FIG. 159A is a detail view of the staple cartridge of FIG. 159;

FIG. 160 is a perspective of the staples of FIG. 158 positioned overdrivers of the staple cartridge of FIG. 159;

FIG. 161 is a perspective view of the drivers of FIG. 160;

FIG. 162 is a cross-sectional view of the staple cartridge of FIG. 159;

FIG. 163 is a second cross-sectional view of the staple cartridge ofFIG. 159;

FIG. 164 is a bottom view of a staple cartridge in accordance with analternative embodiment of the present invention;

FIG. 164A is a detail view of the staple cartridge of FIG. 164;

FIG. 165 is a perspective view of staples in accordance with analternative embodiment of the present invention;

FIG. 166 is a second perspective view of the staples of FIG. 165;

FIG. 167 is a cross-sectional view of the staples of FIG. 165 beingdeployed by a stapler in accordance with an embodiment of the presentinvention;

FIG. 168 is a perspective view of a staple assembly in accordance withan embodiment of the present invention;

FIG. 169 is a top view of the staple assembly of FIG. 168;

FIG. 170 is a perspective view of a staple cartridge configured toreceive the staple assembly of FIG. 169;

FIG. 171 is a top view of the staple cartridge of FIG. 170;

FIG. 172 is a cross-sectional view of the staples of FIG. 168 and thestaple cartridge of FIG. 170;

FIG. 173 is a perspective view of a staple assembly in accordance withan alternative embodiment of the present invention;

FIG. 174 is a perspective view of a staple assembly in accordance withan alternative embodiment of the present invention for formingnon-parallel staple patterns;

FIG. 175 is a top view of the staple of FIG. 174 positioned within astaple cartridge in accordance with an embodiment of the presentinvention;

FIG. 176 is a top view of staples and a staple cartridge in accordancewith an embodiment of the present invention;

FIG. 177 is a detail view of the staple cartridge of FIG. 176; and

FIG. 178 is a cross-sectional view illustrating the shearable deck ofthe staple cartridge of FIG. 176.

DETAILED DESCRIPTION

Turning to the Drawings, wherein like numerals denote like componentsthroughout the several views, in FIG. 1, a surgical stapling andsevering instrument 10 includes a handle portion 12 that is manipulatedto position an implement portion 14 including a fastening end effector,depicted as a staple applying assembly 16, distally attached to anelongate shaft 18. The implement portion 14 is sized for insertionthrough a cannula of a trocar (not shown) for an endoscopic orlaparoscopic surgical procedure with an upper jaw (anvil) 20 and a lowerjaw 22 of the staple applying assembly 16 closed by depression of aclosure trigger 24 toward a pistol grip 26 of the handle portion 12,which advances an outer closure sleeve 28 of the elongate shaft 18 topivot shut the anvil 20.

Once inserted into an insufflated body cavity or lumen, the surgeon mayrotate the implement portion 14 about its longitudinal axis by twistinga shaft rotation knob 30 that engages across a distal end of the handle12 and a proximal end of the elongate shaft 18. Thus positioned, theclosure trigger 24 may be released, opening the anvil 20 so that tissuemay be grasped and positioned. Once satisfied with the tissue held inthe staple applying assembly 16, the surgeon depresses the closuretrigger 24 until locked against the pistol grip 26, clamping tissueinside of the staple applying assembly 16.

Then a firing trigger 32 is depressed, drawn toward the closure trigger24 and pistol grip 26, thereby applying a firing force or motion theretoto distally advance a firing member from an unfired position. The firingmember is depicted as including a proximal firing rod 34 attached to adistal firing bar 36, that is supported within a frame ground 38 thatconnects the handle portion 12 to the staple applying assembly 16.During the staple firing motion, the firing bar 36 engages an elongatestaple channel 40 and actuates a staple cartridge 42 contained therein,both forming the lower jaw 22. The firing bar 36 also engages the closedanvil 20. After releasing the firing trigger 32 to apply a retractionforce or motion to the firing bar 36, depression of a closure releasebutton 44 unclamps the closure trigger 24 so that the closure sleeve 28may be retracted to pivot and open the anvil 20 to release the severedand stapled tissue from the staple applying assembly 16.

It should be appreciated that spatial terms such as vertical,horizontal, right, left etc., are given herein with reference to thefigures assuming that the longitudinal axis of the surgical instrument10 is co-axial to the central axis of the elongate shaft 18, with thetriggers 24, 32 extending downwardly at an acute angle from the bottomof the handle assembly 12. In actual practice, however, the surgicalinstrument 10 may be oriented at various angles and, as such, thesespatial terms are used relative to the surgical instrument 10 itself.Further, “proximal” is used to denote a perspective of a clinician whois behind the handle assembly 12 who places the implement portion 14distal, or away from him or herself. However, surgical instruments areused in many orientations and positions, and these terms are notintended to be limiting and absolute.

In FIG. 2, the staple applying assembly 16 is closed upon compressedtissue 46. In FIGS. 2-3, the firing bar 36 has a proximal portion 48that is attached to a distal E-beam 50 that translates within the stapleapplying assembly 16. As depicted with the firing bar 36 retracted, avertical portion 52 of the E-beam 50 resides essentially aft of thestaple cartridge 42, as after a new staple cartridge 42 has beeninserted into the elongate staple channel 40. An upper pin 54 thatextends laterally from an upper portion of the vertical portion 52 ofthe E-beam 50 initially resides within an anvil pocket 56 recessed neara proximal pivoting end of the anvil 20. As the E-beam 50 is distallyadvanced during the staple firing motion, the vertical portion 52 passesthrough a narrow longitudinal anvil slot 58 (FIGS. 1, 11) formed in astaple forming undersurface 60 of the anvil 20, a proximally openvertical slot 62 formed in cartridge 42 and an underlying longitudinalchannel slot 64 formed in the elongate staple channel 40.

In FIGS. 2, 11, the narrow longitudinal anvil slot 58 (FIG. 2)communicates upwardly to a laterally widened longitudinal anvil channel66 sized to slidingly receive the upper pin 54. The longitudinal channelslot 64 communicates downwardly to a laterally widened longitudinalchannel track 68 that receives a lower foot 70, which is sized to slidetherein and is attached at a bottom of the vertical portion 52 of theE-beam 50. A laterally widened middle pin 72 extending from the verticalportion 52 of the E-beam 50 is positioned to slide along a top surfaceof a bottom tray 74 of the staple cartridge 42, which in turn rests uponthe elongate staple channel 40. A longitudinal firing recess 75 formedin the staple cartridge 42 above the bottom tray 74 is sized to allowthe middle pin 72 to translate through the staple cartridge 42.

A distal driving surface 76 of the vertical portion 52 of the E-beam 50is positioned to translate through the proximally open vertical slot 62of the staple cartridge 42 and distally drive a wedge sled 78 proximallypositioned in the staple cartridge 42. The vertical portion 52 of theE-beam 50 includes a cutting surface 80 along a distal edge above thedistal driving surface 76 and below the upper pin 54 that severs theclamped tissue 46 simultaneously with this stapling.

With particular reference to FIG. 11, it should be appreciated that thewedge sled 78 drives upwardly staple drivers 82 that in turn driveupwardly staples 83 out of staple apertures 84 formed in a staple body85 of the staple cartridge 42 to form against the undersurface 60 of theanvil 20 which is in confronting relationship relative to an uppersurface 43 of staple cartridge 42 (FIG. 2).

In FIGS. 2, 11, advantageously, the illustrative spacing, denoted byarrow 86 (FIG. 2), between the upper pin 54 is compliantly biased towarda compressed state wherein 0.015 inches of compressed tissue 46 iscontained in the staple applying assembly 16. However, a larger amountof compressed tissue 46 up to about 0.025 inches is allowed by aninherent flexure of the E-beam 50. Excessive flexure, of perhaps up to0.030 inches, is avoided should the length of staples be insufficient toform with the additional height. It should be appreciated that thesedimensions are illustrative for a staple height of 0.036 inches. Thesame would be true for each category of staple, however.

In FIG. 4. a first version of a compliant E-beam 50 a includes top andbottom horizontal slits 90, 92 from a distal edge of the verticalportion 52 a, perhaps formed by electro drilling machine (EDM). Thevertical portion 52 a thus contains a vertically compliant top distallyprojecting arm 94 containing the upper pin 54, a knife flange 96containing the cutting surface 80, and a lower vertical portion 98containing the distal driving surface 76, middle pin 72 and lower foot70. The horizontal slits 90, 92 allow a compliant vertical spacing byallowing the top distally arm 94 to pivot upwardly to adjust toincreased force from compressed tissue 46 (not shown).

In FIGS. 5-6, a second version of a compliant E-beam 50 b includes leftand right lower relieved areas 110, 112 formed into an upper pin 54 b toeach side of the vertical portion 52, leaving left and right lowerbearing points 114, 116 respectively. The outboard position of thebearing points 114, 116 provides a long moment arm to exert the force toflex. It should be appreciated given the benefit of the presentdisclosure that the dimensions of the relieved areas 110, 112 and thechoice of materials for the compliant E-beam 50 b may be selected for adesired degree of flexure, given the staple size and otherconsiderations.

In FIG. 7, a third version of a compliant E-beam 50 c is as describedabove in FIGS. 5-6 with further flexure provided by left and right uppernarrow relieved areas 120, 122 formed into opposite top root surfaces ofan upper pin 54 c proximate to the vertical portion 52.

In FIG. 8, a fourth version of a compliant E-beam 50 d is as describedfor FIGS. 2-3 with an added feature of a composite/laminate verticalportion 52 d that includes a central resilient vertical layer 130sandwiched between left and right vertical layers 132, 134 that supportrespectively left and right portions 136, 138 of an upper pin 54 d. Asthe left and right portions 136, 138 are flexed either up or down, theresulting bowing of the left and right vertical layers 132, 134 areaccommodated by a corresponding compression or expansion of the centralresilient vertical layer 130.

In FIG. 9, a fifth version of a compliant E-beam 50 e is as describedfor FIGS. 2-3 with an added feature of a discrete upper pin 54 e formedof a more flexible material that is inserted through a horizontalaperture 140 through a vertical portion 52 e. Thus, left and right outerends 142, 144 of the discrete upper pin 54 e flex in accordance withloading forces.

Alternatively or in addition to incorporating flexure into an upper pin54, in FIGS. 10-11, a sixth version of a compliant E-beam 50 f asdescribed for FIGS. 2-3 further includes resilient pads 150 that areattached to upper surfaces 152 of the bottom foot 70. The resilient pads150 adjust the spacing of the upper pin 54 in accordance to thecompression force experienced at the bottom foot 70.

In FIG. 12, a seventh version of a compliant E-beam 50 g is as describedabove for FIGS. 2-3 with the added feature of a bottom foot (shoe) 70 ghaving an upwardly aft extended spring finger 160 that resiliently urgesthe E-beam 50 g downwardly to adjust vertical spacing in accordance withloading force.

In FIG. 13, an eighth version of a compliant E-beam 50 h is as describedabove in FIGS. 2-3 with the added feature of an oval spring washer 170resting upon the bottom foot 70 encircling the vertical portion 52 andhaving an upwardly bowed central portion 172 that resiliently urges theE-beam 50 h downwardly to adjust vertical spacing in accordance withloading force.

For another example, a compliant E-beam consistent with aspects of thepresent invention may include engagement to an anvil similar to theengagement in the illustrative versions of two structures that slideagainst opposite sides of the elongate staple channel. Similarly, acompliant E-beam may engage a lower jaw by having a laterally widenedportion that slides internally within a channel formed in a lower jawstructure.

As yet an additional example, in the illustrative version, the staplecartridge 42 is replaceable so that the other portions of the stapleapplying assembly 16 may be reused. It should be appreciated given thebenefit of the present disclosure that applications consistent with thepresent invention may include a larger disposable portion, such as adistal portion of an elongate shaft and the upper and lower jaws with astaple cartridge permanently engaged as part of the lower jaw.

As yet another example, the illustrative E-beam advantageouslyaffirmatively spaces the upper and lower jaws from each other. Thus, theE-beam has inwardly engaging surfaces that pull the jaws together duringfiring in instances where a larger amount of compressed tissue tends tospread the jaws. Thereby the E-beam prevents malformation of staples dueto exceeding their effective length. In addition, the E-beam hasoutwardly engaging surfaces that push the jaws apart during firing instances where a small amount of tissue or other structure attributes ofthe instrument tend to pinch the jaws together that may result in staplemalformation. Either or both functions may be enhanced by applicationsconsistent with aspects of the invention wherein inherent flexure in theE-beam adjusts to force to allow a degree of closing of the jaws or ofopening of the jaws.

FIG. 14 is an end cross-sectional view of a surgical instrument 10 athat has a staple applying assembly 16 a of another embodiment of thepresent invention wherein like reference numerals are used to designatelike elements and which employs an elongate channel 40 a for supportinga staple cartridge 42 therein. In various embodiments, the channel 40 ahas resilient or flexible features configured to enable the stapleapplying assembly 40 a to effectively accommodate different thicknessesof tissue. FIG. 15 is a partial perspective view of the staple applyingassembly 16 a with some components shown in cross-section for clarity.As can be seen in FIG. 14, in this embodiment, a first longitudinallyextending relief area 180 and a second longitudinally extending reliefarea 184 are provided in the longitudinal channel 40 a. The firstlongitudinally extending relief area 180 defines a first resilient orflexible channel ledge portion 182 and the second longitudinallyextending relief area 184 defines a second resilient or flexible channelledge portion 186. The elongate channel slot 64 through which the upperend 51 of the vertical portion 52 of the firing member in the form ofE-beam 50 extends is formed between the free ends 183, 185 of theflexible ledges 182, 186, respectively. As can be further seen in FIG.14, such arrangement permits the lower foot 70 of the E-beam 50 to bearupon the flexible ledge portions 182, 186 to accommodate differences inthe thickness of the tissue clamped between the anvil 20 and the lowerjaw 22 as the E-beam 50 transverses therethrough. It will be understoodthat the thickness 188 of the ledge portions 182, 186 may be selected toprovided the desired amount of flexure to those portions of the elongatechannel 40 a. Also, the choice of materials for the elongate channel 40a may be selected for a desired degree of flexure, in view of the staplesize and other considerations.

The elongate channel 40 a as described above may be used in connectionwith a staple applying assembly that employs a conventional anvil 20.That is, the longitudinally extending anvil slot 58 may essentially havea “T” shape that is sized to accommodate the upper pins 54 and an upperend 51 of the vertical portion 52 of the E-beam 50. The embodimentdepicted in FIGS. 14 and 15 employs and anvil 20 a that has resilient orflexible features for further accommodating differences in tissuethicknesses clamped between the anvil 20 a and the lower jaw 22. Inparticular, as can be seen in FIG. 14, a third longitudinally extendingrelief area 190 and a fourth longitudinally extending relief area 194may be provided in the anvil 20 a as shown. The third longitudinallyextending relief area 190 defines a first anvil ledge portion 192 andthe fourth longitudinally extending relief area 194 defines a secondanvil ledge portion 196 upon which the upper pins 54 of the E-beam 50may bear. Such arrangement provides a degree of flexure to the anvil 20a to accommodate differences in tissue thickness clamped between theanvil 20 a and the lower jaw 22. It will be understood that thethickness 198 of the ledge portions 192, 196 may be selected to providedthe desired amount of flexure to those portions of the anvil 20 a. Also,the choice of materials for the anvil 20 a may be selected for a desireddegree of flexure, in view of the staple size and other considerations.Anvil 20 a may be used in connection with the above-described channelarrangement as shown in FIGS. 14 and 15 or it may be employed withconventional channel arrangements without departing from the spirit andscope of the present invention.

The person of ordinary skill in the art will also appreciate that theanvil 20 a and/or the channel 40 a may be successfully employed with aconventional E-beam arrangement or any of the E-beam arrangementsdepicted herein. The E-beams disclosed herein may be reciprocatinglydriven by control arrangements housed within the handle assembly.Examples of such control arrangements are disclosed in U.S. Pat. No.6,978,921, issued Dec. 27, 2005, which has been herein incorporated byreference. Other known firing member configurations and controlarrangements for applying firing and retraction forces or motionsthereto could conceivably be employed without departing from the spiritand scope of the present invention.

FIGS. 16 and 17 illustrate a staple applying assembly 16 b that employsanother version of a channel 40 b and an anvil 20 b that each haveresilient or flexible portions to accommodate differences in tissuethicknesses clamped between the anvil 20 b and the lower jaw 22 b. Ascan be seen in those Figures, a first pair 200 of upper and lowerlongitudinally extending relieved or undercut areas 202, 204 areprovided in the channel 40 b to define a first cantilever-type supportledge 206 and a second pair 210 of relieved or undercut areas 212, 214are provided in the channel 40 b to define a second cantilever-typesupport ledge 216. The first pair relieved areas 202, 204 provide adegree of flexure to the first support ledge 206 to enable it to flex asillustrated by arrow 205. Likewise, the second pair 210 of relievedareas 212, 214 provide a degree of flexure to the second support ledge216 to enable it to flex as illustrated by arrow 215. As with the abovedescribed embodiments, the thickness 208 of the support ledges 206 and216 may be selected to provided the desired amount of flexure to thoseportions of the elongate channel 40 b to accommodate differentthicknesses of tissue. Also, the choice of materials for the elongatechannel 40 b may be selected for a desired degree of flexure, in view ofthe staple size and other considerations.

FIGS. 16 and 17 further illustrate an anvil 20 b that has a T-shapedslot 58 b that defines a first lateral wall portion 220 and a secondlateral wall portion 222. In various embodiments, a first longitudinallyextending undercut area 224 is provided in the first lateral wallportion 220 to define a resilient or flexible first ledge 226.Similarly, in various embodiments, a second longitudinally extendingundercut area 228 is provided in the second lateral wall portion 222 todefine a resilient or flexible second ledge 230. As can be seen in FIG.16, the ends 227, 231 of the first and second ledges 226, 230,respectively serve to define a portion 59 b of anvil sot 58 b throughwhich an upper end portion 51 of E-beam 50 b extends. Such arrangementpermits the upper pins 54 b of the E-beam 50 b may bear upon the firstresilient ledge 226 and the second resilient ledge 230 to provide adegree of flexure to the anvil 20 ab to accommodate differences intissue thickness clamped between the anvil 20 b and the lower jaw 22 b.It will be understood that the thickness 232 of the ledges 226, 230 maybe selected to provided the anvil 20 b with a desired amount of flexureto accommodate different tissue thicknesses. Also, the choice ofmaterials for the anvil 20 b may be selected for a desired degree offlexure, in view of the staple size and other considerations. Anvil 20 bmay be used in connection with the above-described channel 40 b shown inFIGS. 16 and 17 or it may be employed with a conventional channelarrangement. The skilled artisan will also appreciate that the anvil 20a and/or the channel 40 bg may be successfully employed with aconventional E-beam arrangement or any of the E-beams described herein.

FIG. 18 illustrates the cutting and stapling of tissue 240 with any oneof the various surgical cutting and stapling instrument embodiments ofthe present invention. A portion 242 of the tissue 240 illustrated inFIG. 18 has already been cut and stapled. After the clinician has cutand stapled the first portion 242, the instrument would be withdrawn toenable new staple cartridge 42 to be installed. FIG. 18 illustrates theposition of the implement portion 14 prior to commencing the secondcutting and stapling process. As can be seen in that Figure, the portion242 of the tissue 240 that has been stapled has a thickness 243 that isless than the thickness 245 of other portions 244 of the tissue 240.

FIG. 19 is a view of the underside of an anvil 20 c that may be employedwith a staple applying assembly 16 c of various embodiments of thepresent invention. The anvil 20 c includes and anvil body 21 c thatsupports movable staple forming pockets that define different staplezones. In the embodiment depicted in FIG. 19, four left staple zones252, 254, 256, 258 are provided on a left side 250 of the anvil slot 58c and four right staple zones 262, 264, 266, 268 are provided on a rightside 260 of the anvil slot 58 c within the anvil body 21 c. The firstleft staple zone 252 is defined by a first left staple forming insertmember 270 that has a series of staple forming pockets 272 therein. Inthis embodiment, three rows 274, 276, 278 of staple forming pockets 272are provided in the insert 270. As can be seen in FIG. 19, the centralrow 276 of pockets 272 are slightly longitudinally offset from the outertwo rows 274, 278 of pockets 272 and correspond to the arrangement ofthe corresponding staple apertures 84 in corresponding staple cartridges42. Those of ordinary skill in the art will appreciate that sucharrangement serves to result in the application of the staples 83 in astaggered manner as illustrated in FIG. 18.

Similarly, the second left staple zone 254 may be defined by a secondleft staple forming insert 280 that may have three rows 282, 284, 286 ofstaple forming pockets 272 therein. The third left staple zone 256 maybe defined by a third left staple forming insert 290 that may have threerows 292, 294, 296 of staple forming pockets 272 therein. The fourthleft staple zone 258 may be defined by a fourth left staple forminginsert 300 that may have three rows 302, 304, 306 of staple formingpockets 272 therein. The first, second, third and fourth left stapleforming inserts 270, 280, 290, 300 are longitudinally aligned in a leftside cavity 251 provided in the anvil 20 c on the left side 250 of theanvil slot 58.

The first right staple zone 262 may be defined by a first right stapleforming insert member 310 that has a series of staple forming pockets272 therein. In this embodiment, three rows 312, 314, 316 of stapleforming pockets 272 are provided in the insert 310. As can be seen inFIG. 19, the central row 314 of staple forming pockets 272 are slightlylongitudinally offset from the outer two rows 312, 316 and correspond tothe arrangement of the corresponding staple apertures 84 incorresponding staple cartridges 42. Such arrangement serves to result inthe application of the staples 83 in a staggered manner on the rightside of the tissue cut line. The second right staple zone 264 may bedefined by a second right insert 320 that may have three rows 322, 324,326 of staple forming pockets 272 therein. The third right staple zone266 may be defined by a third right staple forming insert 330 that mayhave three rows 332, 334, 336 of staple forming pockets 272 therein. Thefourth right staple zone 268 may be defined by a fourth right stapleforming insert 340 that may have three rows 342, 344, 346 of stapleforming pockets 272 therein. The first, second, third, and fourth rightstaple forming inserts 310, 320, 33, 340 are longitudinally aligned in aright side cavity 261 provided in the anvil 20 c on the right side 260of the anvil slot 58. In various embodiments, the staple forming insertsmay be fabricated from stainless steel or other suitable materials thatare harder than the material from which the staples are fabricated. Forexample, the inserts may be successfully fabricated from other materialssuch as cobalt chromium, aluminum, 17-4 stainless steel, 300 seriesstainless steel, 400 series stainless steel, other precipitant hardenedstainless steels, etc.

At least one biasing member or compliant member in the form of a wavespring 350 or other suitable biasing or compliant medium or membercorresponding to each of the staple forming inserts 270, 280, 290, 300,310, 320, 330, 340 is provided between the respective left stapleforming inserts 270, 280, 290, 300 and the bottom of the left sidecavity 251 as shown in FIGS. 20-23. Wave springs 350 or other suitablebiasing or compliant medium or member is also provided between each ofthe right staple forming inserts 310, 320, 330, 340 and the bottomsurface of the right side cavity 261. The wave springs 350 on the leftside of the anvil slot 58 c may be received in a corresponding springcavity 253 and the wave springs 350 on the right side of the anvilcavity 58 c may be received in a corresponding spring cavity 263. Tobiasingly retain each insert 270, 280, 290, 300, 310, 320, 330, 340 inthe anvil 20 c, each insert 270, 280, 290, 300, 310, 320, 330, 340 maybe attached to its corresponding spring 350 or biasing member by, forexample, adhesive or other fastener arrangements. In addition, eachspring 350 may be attached to the anvil 20 c by, for example, adhesiveor other mechanical fastener arrangements to retain a portion of thewave spring 350 within its respective spring cavity 253 or 263. Suchspring/biasing member arrangements serve to bias the inserts 270, 280,290, 300, 310, 320, 330, 340 toward the tissue 240 and staples andessentially act as resilient “shock absorbers” to accommodatedifferences in tissue thicknesses. This advantage is illustrated inFIGS. 22-24.

In particular, as can be seen in FIG. 22, the portion 242 of the tissue240 clamped in the proximal end 17 b of the staple applying assembly 16c has a first thickness (arrow 243) that is thicker than the thickness(arrow 245) of the portion 244 of tissue 240 clamped in the centralportion 17 c of the staple applying assembly 16 c. The thickness 245 oftissue portion 244 is greater than the thickness (arrow 247) of theportion 246 of tissue 240 that is clamped in the distal end 17 a of thestaple applying assembly 16 c. Thus, the staples 83 formed in the distalportion 17 a of the staple applying assembly 16 c are more tightlyformed that the staples 83 formed in the central portion 17 c of thestaple applying assembly 16 c which are more tightly formed than thosestaples 83 formed in the proximal end 17 b of the staple applyingassembly 16 c due to the differences in tissue thicknesses. FIG. 23further illustrates the variations in staple formation heights basedupon the variations in the thicknesses of the tissue clamped within thestaple applying assembly 16 c. FIG. 24 illustrates a condition whereinthe tissue 240 clamped in the central portion 17 c of the stapleapplying assembly 16 c is thicker than the portions of tissue clamped inthe distal and proximal ends of the staple applying assembly 16 c. Thus,the formation heights of the staples in the central portion 17 c will behigher than the staple formation heights of the staples associated withthe proximal end 17 b and distal end 17 a of the staple applyingassembly 16 c.

Those of ordinary skill in the art will understand that the unique andnovel features of the embodiments depicted in FIGS. 19-24 may also beemployed in connection with a staple applying assembly that isessentially identical in construction and operation to staple applyingassembly 16 c described above, except that the staple forming inserts270, 280, 290, 300, 310, 320, 330, 340 may have just one row of stapleformation pockets 272 therein or two rows of staple formation pockets272 therein. For example, FIG. 25 illustrates an embodiment that onlyapplies two rows of staples on each side of the tissue cut line. Shownin that Figure are staple forming inserts 270 d and 310 d that only havetwo rows of staple forming pockets 272 d each.

The skilled artisan will further understand that the number of stapleforming inserts employed on each side of the anvil slot 58 may vary. Forexample a single longitudinally extending insert may be used on eachside of the anvil slot 58. FIG. 26 illustrates another staple applyingassembly 16 e of the present invention that only employs one stapleforming insert on each side of the anvil slot. FIG. 26 depicts across-sectional view of the left side of an anvil 20 e that supports asingle left staple forming insert 380 that is attached to a single wavespring 350 e. Other biasing members or multiple wave springs or biasingmembers may also be employed. The biasing member or members 350 e aresupported in the left side cavity 251 e and attached to the anvil 20 ein one of the various manners described above. A similar rights sideinsert (not shown) would be employed on the right side of the anvil slot58. Furthermore, although FIGS. 19-24 depict use of four staple forminginserts on each side of the anvil slot greater numbers of staple forminginserts may be employed.

FIGS. 27-29 illustrate another staple applying assembly 16 f of thepresent invention wherein a separate movable staple forming insert isprovided for each staple 83. In particular, as can be seen in FIG. 27, asingle staple forming insert 400 is provided for each staple 83. Eachstaple forming insert 400 may have staple forming pockets 404 formed onits underside 402 thereof for forming the ends of the correspondingstaple 83. As with various embodiment described above, each insert 400has a biasing member 412 associated therewith. In the example depictedin FIGS. 27-29, the biasing members 412 comprise stamped portions of abiasing plate 410. The biasing plate 410 may comprise a piece of metalor other suitable material wherein each biasing member 412 is stamped orotherwise cut and formed to correspond with a staple forming insert 400.The biasing plate 410 may comprise a single plate that is supportedwithin a cavity 251 f in the anvil 20 f or multiple plates 410 may beemployed on each side of the anvil slot. It will be understood that asimilar arrangement may be employed on the right side of the anvil sot.Each staple forming insert 400 may be attached to its correspondingbiasing member 412 by adhesive or other suitable fastener arrangement.Thus, it will be appreciated that a variety of different numbers andarrangements of movable staple forming inserts may be employed withoutdeparting from the spirit and scope of the present invention. Inparticular, at least one movable staple forming insert may be employedon each side of the anvil slot.

FIGS. 30-32 illustrate another staple applying assembly 16 g of otherembodiments of the present invention wherein the biasing or compliantmedium between the staple forming inserts and the anvil comprises atleast one fluid bladder. More specifically, as can be seen in FIG. 30, aleft bladder 420 is positioned within a left side cavity 253 g on theleft side of the anvil slot 58 g in the anvil 20 g. Likewise, a rightside bladder 430 is positioned with a right side cavity 263 in the anvil20 g. The series of left side staple forming inserts 270 g, 280 g, 290g, 300 g may be attached to the left side bladder 430 by a suitableadhesive or other fastener arrangement. Likewise the right side stapleforming inserts (not shown) may be attached to the right side bladder430 by adhesive or other suitable fastener arrangements. In oneembodiment, each bladder 420, 430 is sealed and partially filled with aliquid 432 such as, for example, glycerin oil or saline solution. Thoseof ordinary skill in the art will appreciate that such arrangement willpermit the staple forming inserts to move to better accommodatevariations in the thickness of the tissue clamped within the stapleapplying assembly 16 g. For example, for tissues that have a relativelyconstant thickness, the liquid 432 will be relatively evenly distributedwithin each of the bladders 420, 430 to provide a relatively evensupport arrangement for the staple forming inserts. See FIG. 31.However, when a thicker portion of tissue is encountered, those stapleforming inserts corresponding to the thicker tissue will be compressedinto their respective anvil cavity thereby forcing the liquid in thatpart of the bladder to the portions of the bladder corresponding to thethinner tissue portions. See FIG. 32.

In some applications, it may be desirable for the clinician to be ableto control the amount of pressure within the bladders 420, 430. Forexample, less pressure may be desirable when cutting and stapling moredelicate tissues such as lung tissue and the like. More pressure may bedesirable when cutting and stapling thicker tissues such as, forexample, stomach tissue, intestine tissue, kidney tissue, etc. Toprovide the clinician with this additional flexibility, the bladders420, 430 may each be fluidically coupled by a supply line 440 or conduitto a fluid reservoir 450 supported by the handle portion 12 of theinstrument. In the embodiment illustrated in FIG. 33, the clinician canincrease or decrease the amount of fluid within the bladders 420, 430and resulting pressure therein by means of an adjustment mechanism 460mounted to the fluid reservoir 450. In various embodiments, theadjustment mechanism 460 may comprise a piston 462 that is attached toan adjustment screw 464. By adjusting the adjustment screw 464 inward,the piston 462 forces fluid out of the reservoir 450 to the bladders420, 430. Conversely, by reversing the adjustment screw 464, the piston462 permits more fluid 432 to return or remain within the reservoir 450.To assist the clinician in determining the amount of pressure withinthat hydraulic system, generally designated as 405, a pressure gauge 470may be employed as shown. Thus, for those tissues requiring a higheramount of pressure, the clinician can preset the pressure in thebladders 420, 430 to a pressure that is conducive to successfully clampand staple that particular type of tissue. While a piston/screwarrangement has been described for controlling the pressure in thehydraulic system, the skilled artisan will understand that other controlmechanisms could successfully be employed without departing from thespirit and scope of the present invention.

FIG. 30A illustrates another staple applying assembly 16 hg of otherembodiments of the present invention wherein the biasing or compliantmedium between the staple forming inserts and the anvil comprises atleast one compressible polymer member. More specifically, as can be seenin FIG. 30A, a left compressible polymer member 420 h is positionedwithin a left side cavity 253 h on the left side of the anvil slot 58 hin the anvil 20 h. Likewise, a right side compressible polymer member430 h is positioned with a right side cavity 263 h in the anvil 20 h.The series of left side staple forming inserts 270 h-300 h may beattached to the left compressible polymer member 420 h by a suitableadhesive or other fastener arrangement. Likewise the right side stapleforming inserts 310 h-340 h may be attached to the right sidecompressible polymer member 430 h by adhesive or other suitable fastenerarrangements.

FIGS. 34-37 depict a unique and novel collapsible or compressible stapledriver arrangement that enables the various staple drivers toaccommodate different tissue thicknesses by collapsing or compressing inresponse to compression forces that the driver encounters during thefiring process. As used herein, the term “firing process” refers to theprocess of driving the staple drivers towards the staple formingundersurface of the anvil. As was mentioned above, prior staple driverswere fabricated from stiff/rigid material designed to resist deflectionand deformation when encountering compression forces during the firingprocess. A variety of such driver configurations are known. For example,some staple drivers are configured to support a single staple and othersare designed to support multiple staples. A discussion of single anddouble staple drivers and how they may be operably supported and firedwithin a staple cartridge is found in U.S. patent application Ser. No.11/216,562, filed Sep. 9, 2005, entitled Staple Cartridges For FormingStaples Having Differing Formed Staple Heights to Frederick E. Shelton,IV, the disclosure of which is herein incorporated by reference.

FIG. 34 depicts a staple applying assembly 16 h that includes anelongate channel 40 h that has an anvil 20 h pivotally coupled theretoin a known manner. The elongate channel 40 h is configured to operablysupport a staple cartridge 42 h therein. The anvil 20 h has a stapleforming undersurface 60 h thereon that is adapted to confront the uppersurface 43 h of the staple cartridge 42 h when the anvil 20 h is pivotedto the closed position shown in FIG. 34. The staples 83 are eachsupported on a corresponding staple driver 500, the construction ofwhich will be discussed in further detail below.

Each staple driver 500 may be movably supported within a correspondingstaple channel 87 h provided in the cartridge body 85 h as shown inFIGS. 34 and 35. Also operably supported within the cartridge body 85 his a driving member or wedge sled 78 that is oriented for engagement bythe E-beam firing member 50 during the firing process. See FIG. 34. Asthe E-beam firing member 50 and wedge sled 78 are driven distallythrough the elongate channel 40 h and staple cartridge 42 in a knownmanner, the wedge sled 78 drives the staple drivers 500 upwardly withinthe cartridge body 85 h. As the staple drivers 500 are driven upwardlytoward the staple forming undersurface 60 h of the anvil 20 h, theycarry with them their respective staple 83 or staples which are driveninto forming engagement with the corresponding staple forming pockets 61h in the staple forming undersurface 60 h of the anvil 20 h. As the ends88 of the staple 83 contact the forming pockets 61 h, they are bent overthus providing the staple 83 with a shape that somewhat resembles a “B”.While the various embodiments of the present invention have beendescribed herein in connection with E-beam firing members, it isconceivable that these various embodiments may also be successfullyemployed with a variety of different firing member and driving memberarrangements without departing from the spirit and scope of the presentinvention.

One collapsible staple driver embodiment of the present invention isdepicted in FIGS. 36 and 37. As can be seen in those Figures, thecollapsible or compressible staple driver 500 includes a base portion502 and a staple supporting portion 520 that is movable from a firstuncollapsed position relative to the base portion 502 in response tocompression forces generated during the firing process. In variousembodiments, the base portion 502 may have a forward support columnsegment 504 and a rearward support column segment 508 that is spacedfrom the forward support column segment 504 and is substantiallyintegrally formed therewith. The base portion 502 may also have anupstanding side portion 510 that has a rib 512 protruding from abackside therefrom. The upstanding side portion 510 serves to define areceiving ledge 514 in the base portion 502 for receiving the staplesupporting portion 520 thereon. Those of ordinary skill in the art willunderstand that when the staple supporting portion 520 is received onthe ledge 514, the staple driver 500 is unable to collapse or compressany further.

The staple supporting portion 520 of the staple driver 500 may similarlyinclude a forward support column segment 522 and rearward support columnsegment 524 that is spaced from the forward support column segment 522.When the staple supporting portion 520 is received on the base portion502, the forward support column segments 504, 522 serve to form aforward column portion 530 and the reward column segments 508, 524 forma rearward column portion 532. A forward staple receiving groove 526 isformed in the forward support column segment 522 and a rearward staplereceiving groove 528 is formed in the rearward support column segment524. The forward staple receiving groove 526 and the rearward staplereceiving groove 528 serve to support a staple 83 therein as illustratedin FIG. 35. The rib 512 and the forward column 530 and rearward column532 may cooperate with corresponding channels (not shown) in the staplecartridge body 85 to provide lateral support to the staple driver 500while permitting the driver to be driven upward within the cartridgebody 85 during the firing process.

In various embodiments, a resistive attachment structure, generallydesignated as 540′ is provided to support the staple supporting portion520 in a first uncompressed or uncollapsed orientation relative to thebase portion (FIG. 37) prior to encountering any compressive forcesduring the firing operation and to permit the staple supporting portion520 and the base portion to move towards each other (collapse orcompress) in response to the magnitude of the compression forces appliedto the staple supporting portion 520 and base portion 520 during thestaple firing operation. As can be seen in FIGS. 36 and 37, theresistive attachment structure 540′ in various embodiments may comprisea pair of attachment rods 540 that protrude from the bottom 521 of thestaple supporting portion 520 and correspond to holes or apertures 542in the base portion 502. The rods 540 are sized and shaped relative tothe holes 542 to establish an interference fit or “light press fit”(i.e., an interference of approximately 0.001 inches) therebetween suchthat when the staple supporting portion 520 and base driver portion 502are compressed together during the staple firing operation as will bediscussed in further detail below, the staple supporting portion 520 andthe base portion 502 can compress toward each other to reduce theoverall height of the staple driver 500 in relation to the amount ofcompression force encountered during the firing process. In variousembodiments, for example, the staple supporting portion 520 and baseportion 520 may be fabricated from the same material such as, forexample, plastic material such as ULTEM®. In other embodiments, the baseportion 502 and the staple supporting portion 520 may be fabricated fromdifferent materials. For example, staple supporting portion 520 may befabricated from ULTEM® and base portion 502 may be fabricated from glassor mineral filled ULTEM®. However, other materials could also beemployed. For example, the base portion 502 could be fabricated fromNylon 6/6 or Nylon 6/12.

In various embodiments, a frictional or an interference fit ofapproximately 0.001 inch may be established between the attachment rods540 and their corresponding holes 542. However, other degrees ofinterference fit may be employed to attain the desired amount and rateof driver compression in proportion to the magnitude of compressionforces encountered when stapling a particular type/thickness of tissue.For example, in one embodiment, the degree of interference fit betweenthe attachment rods 540 and their respective holes 542 may beapproximately 0.002 to 0.005 inches for stapling tissues wherein it isanticipated that compression forces on the order of 2-5 pounds may begenerated during the firing operation.

FIG. 35 illustrates various ranges of travel and compression that thestaple drivers 500 may experience when encountering tissues of varyingthicknesses. More specifically, FIG. 35 illustrates a portion of tissue560 clamped between the upper surface 43 h of the staple cartridge 42 hand the staple forming undersurface 60 h of the anvil 20 h. Asillustrated in FIG. 35, the tissue 560 has three thicknesses. Thethickest portion of tissue is designated as 562 and comprises theportion of tissue that is on the right side of the Figure. The nextthickness portion of tissue is designated as 564 and the thinnestportion of tissue 560 is designated as 566 and is on the left side ofthe Figure. For the purposes of this explanation, the staple driverassociated with tissue portion 562 is designated as staple driver 500 a.The staple driver associated with tissue portion 564 is designated asstaple driver 500 b and the staple driver associated with tissue portion566 is designated as 500 c. It will be understood that staple drivers500 a, 500 b, 500 c, may be identical in construction to staple driver500 as described above.

Turning to staple driver 500 a first, as the staple driver 500 a isdriven upwardly towards the staple forming undersurface 60 h of theanvil 20 h by the wedge sled (not shown in FIG. 35), it encounters thethick tissue portion 562 which resists the upward movement of the stapledriver 500 a. Such resistive force (represented by arrow 570) opposesthe drive force (represented by arrow 572) generated by the wedge sledand serves to overcome the amount of interference established betweenthe attachment rods 540 and their respective holes 542 and forces therods 540 deeper into their respective holes 542 to thereby permit thestaple supporting portion 520 a of the staple driver 500 a and baseportion 502 a to move toward each other. This movement of the staplesupporting portion 520 a and base portion 502 a towards each other undera compressive force generated during the staple firing operation isreferred to herein as “collapsing” or “compressing”. When in thecompletely compressed position wherein the staple supporting portion 520a is received on the ledge 514 a of the base portion 502 a, the staplesupporting ledges 526 a, 528 a on the staple supporting portion 520 amay preferably support the bottom cross member 89 of the staple 83 abovethe upper surface 43 h of the staple cartridge 42 h to avoid catchingthe staple 83 on the staple cartridge 42 h when the staple applyingassembly 16 h is withdrawn. The compressed height of the staple driver500 a is designated by arrow 574 in FIG. 35.

Turning next to staple driver 500 b which corresponds to tissue portion564, because the tissue portion 564 is not as thick as tissue portion562, the resistive force 570 b encountered by the staple driver 500 bduring the firing operation is not as great as resistive force 570.Therefore, the attachment pins 540 b of staple driver 500 b are notadvanced into their respective holes 542 b as far as the pins 540 ofstaple driver 500 a were advanced into their respective holes 542. Thus,the compressed height 576 of staple driver 500 b is greater than thecompressed height 574 of staple driver 500 a. As can also be seen inFIG. 35, the bottom portion 89 of the staple 83 supported in stapledriver 500 b is supported above the upper surface 43 h of the staplecartridge 42 h.

Staple driver 500 c is associated with the thinnest tissue portion 566.Thus, the resistive force 570 c encountered by the staple driver 500 cduring the staple firing operation is less than the resistive force 570b that was encountered by staple driver 500 b. Thus, the pins 540 c ofstaple driver 500 c are not advanced into their respective holes 542 cas far as the pins 540 b of staple driver 500 b were advanced into theirrespective holes 542 b. Thus, the compressed height 578 of staple driver500 c is greater than the compressed height 576 of staple driver 500 b.

As can be further seen in FIG. 35, because the compressed height 578 ofstaple driver 500 c is greater than the compressed height 576 of stapledriver 500 b, the staple 83 c supported by staple driver 500 c wascompressed to a greater extent than the staple 83 b that was supportedby staple driver 500 b. Thus, the formed height of staple 83 c is lessthan the formed height of staple 83 b which is less than the formedheight of staple 83 a as illustrated in FIG. 35.

Those of ordinary skill in the art will appreciate that the number,shape, composition and size of the attachment rods and their respectiveholes can vary from embodiment to embodiment without departing from thespirit and scope of the present invention. Such interrelationshipbetween the attachment rods and their respective holes serves toestablish an amount of frictional interference therebetween which can beovercome in relation to various compression forces encountered whenclamping/stapling different thicknesses of tissue. In an alternativeversion, the attachment to rods 540 may be formed on the base portion502 and the holes provided in the staple supporting portion 520.

FIGS. 38 and 39 illustrate another staple driver 500 d embodiment of thepresent invention that may be substantially identical in constructionand operation to the staple drivers 500 described above, except that theattachment rods 540 d are somewhat tapered or frusto-conically shaped.In various embodiments, for example, the ends 541 d of the attachmentrods 540 d may be sized relative to holes 542 such that a light pressfit is established therebetween when in the first uncollapsed statedepicted in FIG. 39. The degree of taper of the attachment rods 540 dmay be tailored to attain the desired amount of staple drivercompression in relation to the magnitude of compression forcesencountered during the staple firing process. Thus, in theseembodiments, the magnitude of the interference fit between theattachment rods 540 d and the holes 542 increases as the staple driver500 d encounters greater compression forces which drive the attachmentrods 540 d deeper into their respective holes 542 d. In alternativeembodiments, the attachment rods 540 may have a round shape and theholes 542 may be tapered to attain the desired amount and rate of stapledriver compression in proportion to the amount of anticipatedcompression forces applied thereto during the firing operation. In analternative version, the attachment rods 540 d may be formed on the baseportion 502 and the holes 542 be formed in the staple supporting portion520.

FIGS. 40-43 illustrate another staple driver 500 e embodiment of thepresent invention that may be substantially identical in constructionand operation to the staple drivers 500 described above, except that theattachment rods 540 e are configured or shaped to include an additionalamount of material oriented to be sheared off of the remaining portionof the rods as the staple driver 500 e encounters compression forcesduring the firing operation. More specifically and with reference toFIG. 42, the attachment rods 540 e have a tip portion 541 e that isreceived within the corresponding hole 542 e. The tip portion 541 e maybe sized relative to the hole 542 e such that a sliding fit is achievedtherebetween or, in other embodiments, a small interference fit may beestablished between those components when in the first uncollapsedposition. The remaining portion 543 e of each attachment rod 540 e maybe provided or formed with an additional amount of material 545 e thatis designed to be sheared therefrom as the staple driver 500 eencounters the anticipated compression forces during the firingoperation. See FIG. 43. The additional material 545 e may extendcompletely around the circumference of the portion 543 e of eachattachment rod 540 e or the material 543 e may comprise one or moresegments oriented around the circumference of the attachment rod 540 e.For example, in the embodiment depicted in FIGS. 40-43, two segments 547e of material 543 e are diametrically opposed on each attachment rod 540e as shown. In various embodiments, the diametric distance between thesegments may be somewhat larger than the diameter of the holes 542 e tocause the segments 547 e to be sheared or removed from at least aportion of the rods 540 e as the staple driver 500 e encounters theanticipated compression forces during the firing operation.

The portions of additional material 543 e may comprise an integralportion of the attachment rod 540 e or the additional material 543 e maycomprise a second material applied to the attachment rod 540 e anddesigned to shear off therefrom when the staple driver 500 e encountersthe anticipated compression forces. In various embodiments, the baseportion 502 may be fabricated from a material that is more rigid thatthe material from which attachment rods 540 e and/or the additionalmaterial 543 e are fabricated such that the base portion 502 facilitatesthe shearing off of additional material 543 e as the staple supportportion 520 e and base portion 502 e are compressed together during thestaple firing operation. In an alternative version, the attachment rods540 e may be formed on the base portion 502 and the holes 542 e beprovided in the staple supporting portion 520 e.

FIGS. 44-46 illustrate another staple driver 500 f of the presentinvention that may be substantially identical in construction andoperation to the staple drivers 500 described above, except that theholes 542 f in the base portion 502 f may be hexagonally shaped or mayhave one or more surfaces therein designed to establish an interferencefit with the attached rods 540 or to otherwise resist further entry ofthe attachment rods 540 into the holes 542 f. For example, the holes 542f shown have a pair of flat surfaces 551 f formed therein that serve toestablish an interference fit or a degree of frictional resistancebetween the attachment rods 540 f and the holes 542 f which can beovercome by the various compression forces encountered whenclamping/stapling different thicknesses of tissue. In the embodimentdepicted in FIGS. 44-46, the attachment rods 540 have a substantiallycircular cross-sectional shape and the holes 542 f have flat surfaces551 formed therein. In alternative embodiments, however, the holes 542may be round and the flat surfaces may be formed on the attachment rods540. In an alternative version, the attachment rods 540 may be providedon the base portion 502 f and the holes 542 f be provided in the staplesupporting portion 520.

FIGS. 47-49 illustrate another staple driver 500 g of the presentinvention that comprises a base portion 502 g and a staple supportingportion 520 g. The staple supporting portion 520 g has staple supportinggrooves (not shown) formed therein and a downwardly protruding tang 580protruding from its undersurface 521 g. The tang 580 has two taperedsurfaces 582 and is shaped to be received in a corresponding cavity 590formed in the base portion 502 g. The cavity 590 is formed with taperedsides 592 and is sized to receive the tang 580 therein in the followingmanner. As the driver staple 500 g encounters the compression forcesgenerated during the firing operation, the tang 580 is forced into thecavity 590. FIG. 49 illustrates the staple driver 500 g in a fullycollapsed or compressed position. The staple supporting portion 520 gand/or tang 580 may be fabricated from a material that is somewhat morecompliant than the material from which the base portion 502 g is formedso that the tang 580 can be forced into the cavity 590 in the baseportion 502 g without substantially distorting the base portion 502 g tothe extent that it would hamper the ability of the staple driver 500 gto be fully driven to a final firing position. For example, the staplesupporting portion and/or the tang 580 may be fabricated from ULTEM® andthe base portion 502 g may be fabricated from glass filled Nylon toachieve the desired amount of driver compression when encountering theanticipated compression forces during the firing operation. In analternative version, the tang 580 may be provided on the base portion502 g and the hole 590 be provided in the staple supporting portion 520g.

FIGS. 50-52 illustrate another staple driver 500 h embodiment of thepresent invention that may be substantially identical in constructionand operation to the staple drivers 500 described above, except that,instead of attachment rods, the staple supporting portion 520 h has twotapered tangs 600 protruding therefrom designed to be compressed into aV-shaped cavity 610 formed in the base portion 502 h. Prior tocommencement of the firing operation, the staple supporting portion 520h is supported on the base portion 502 h within the staple cartridge. Asthe staple supporting portion 520 h and the base portion 502 h arecompressed together during the firing operation, the tapered tangs 600are forced inwardly as shown in FIG. 52. The degree to which the tangs600 are compressed into the V-shaped cavity 610 is dependent upon themagnitude of the compression forces encountered during the firingoperation.

The staple supporting portion 500 h and/or tangs 600 may be fabricatedfrom a material that is somewhat more compliant than the material fromwhich the base portion 502 h is formed so that the tangs 560 can beforced into the V-shaped cavity 610 in the base portion 502 h withoutsubstantially distorting the base portion 502 h to the extent that itwould hamper the ability of the staple driver 500 h to be fully drivento a final firing position. For example, the staple supporting portionand/or the tangs 600 may be fabricated from Nylon with no fill and thebase portion 502 h may be fabricated from ULTEM® with a glass or mineralfill to achieve the desired amount of staple driver compression whenencountering the anticipated compression forces during the firingoperation. In an alternative version, the tangs 600 may be provided onthe base portion 502 h and the cavity 610 may be provided in the staplesupporting portion 520 h.

FIGS. 53-55 illustrate yet another staple driver 500 i embodiment of thepresent invention that includes a staple supporting portion 520 i thathas V-shaped staple supporting grooves 630 i, 650 i therein. In thisembodiment, the staple supporting portion 520 i has a first pair 620 iof two tapered tangs 622 i, 626 i protruding therefrom oriented to becompressed into the first V-shaped groove or cavity 630 i and a secondpair 640 i of two tapered tangs 642 i, 646 i oriented to be compressedinto the second V-shaped groove or cavity 650 i. More specifically andwith reference to FIG. 54, the first tang 622 i has an end 624 i that isspaced from an end 628 i of the second tang 626 i prior to commencementof the staple firing operation. When in the position illustrated in FIG.54, the ends 624 i, 628 i are biased outwardly into frictional contactwith the upper side walls of the first V-shaped groove 630 i to retainthe staple supporting portion 520 i in the uncollapsed position shown inFIG. 54. Although not shown, the second pair 640 i of tangs 642 i, 646 iare also similarly configured as tangs 622 i, 626 i and serve to engagethe second V-shaped groove 650 i in the same manner.

As the staple supporting portion 520 i and the base portion 502 i arecompressed together during the firing operation, the ends 624 i, 628 iof the first tangs 622 i, 626 i and the ends of the second tangs 642 i,646 i are biased toward each other to permit the tangs to be drivendeeper into their respective grooves 630 i, 650 i. FIG. 55 illustratesthe first pair 620 i of tangs 622 i, 626 i in their fully compressedstate which also corresponds to the fully compressed state of the driver500 i. The degree to which the tangs are compressed into theirrespective V-shaped grooves is dependent upon the magnitude of thecompression forces encountered during the firing operation.

The staple supporting portion 500 i and/or tangs 622 i, 626 i, 642 i,646 i may be fabricated from a material that is somewhat more compliantthan the material from which the base portion 502 i is formed so thatthe tangs 622 i, 626 i, 642 i, 646 i can be forced into their respectiveV-shaped grooves in the base portion 502 i without substantiallydistorting the base portion 502 i to the extent that it would hamper theability of the driver 500 i to be fully driven to a final firingposition. For example, the staple supporting portion 520 i and/or thetangs 622 i, 626 i, 642 i, 646 i may be fabricated from ULTEM® and thebase portion 502 i may be fabricated from Nylon with a glass or mineralfill to achieve the desired amount of driver compression whenencountering the anticipated compression forces during the firingoperation. In an alternative version, the tangs 622 i, 626 i, 642 i, 646i may be provided on the base portion 502 i and the V-shaped grooves 630i, 650 i may be provided in the staple supporting portion 520 i.

The various embodiments of the present invention described above andtheir respective equivalent structures represent vast improvements overprior staple applying assemblies and end effectors. Various embodimentsof the present invention provide anvils and/or channels with flexibleportions that permit the overall staple height to increase as thecompression within the assembly increases due to tissue thickness. Otherembodiments employ anvil arrangements that have flexible forming pocketsthat can be compressed away from the staple cartridge in response tovariations in tissue thickness. In doing so, the inherent gap betweenthe forming pocket and the cartridge increases which serves to increasethe formed height of the staple. Such advantages can result in improvedstaple line consistency and provide better clinical outcomes.

FIGS. 56-63 illustrate another surgical stapling and severing instrument1000 of the present invention. As can be seen in FIG. 56, the instrument1000 includes a handle assembly 1020 that is manipulated to position animplement portion 1014 including a fastening end effector, depicted as astaple applying assembly 1016, distally attached to an elongate shaftassembly 1100. The implement portion 1014 is sized for insertion througha cannula of a trocar (not shown) for an endoscopic or laparoscopicsurgical procedure with an upper jaw (anvil) 1050 and a lower jaw 1018of the staple applying assembly 1016 closed by depression of a closuretrigger 1040 toward a pistol grip 1034 of the handle assembly 1020,which advances an outer closure tube assembly 1130 of the elongate shaftassembly 1100 to pivot the anvil 1050 to a closed position as will bediscussed in further detail below.

Once inserted into an insufflated body cavity or lumen, the closuretrigger 1040 may be released, opening the anvil 1050 so that tissue maybe grasped and positioned. Once satisfied with the tissue held in thestaple applying assembly 1016, the surgeon depresses the closure trigger1040 until locked against the pistol grip 1034, clamping tissue insideof the staple applying assembly 1016. Then a firing trigger 1046 isdrawn toward the closure trigger 1040 and pistol grip 1034, therebyapplying a firing force or motion thereto to distally advance a firingmember supported with in the implement 1014 from an unfired position. Asthe firing member advances through the implement or end effector 1014 ina known manner, it severs the tissue clamped within the end effector1014 and fires or drives the staples contained with the staple cartridge42 supported therein.

As depicted in FIG. 57, this embodiment may employ the firing bar 36 andE-Beam 50 arrangements described above. In other alternativeembodiments, the E-Beam arrangements described in U.S. patentapplication Ser. No. 11/231,456, filed Sep. 21, 2005 and entitled“Surgical Stapling Instrument Having Force Controlled Spacing EndEffector”, the disclosure of which is herein incorporated by referencemay also be employed. In addition, as the present Detailed Descriptionproceeds, those of ordinary skill in the art will appreciate that theadvantages provided by these embodiments of the present invention may beeffectively attained when used in connection with other known non-E beamfiring bar configurations. Thus, these embodiments of the presentinvention should not be limited solely to use in connection with E-beamtype firing and cutting arrangements.

FIG. 57 depicts the firing bar 36 as including a proximal firing rod 34,that is supported within a “frame ground” or spine assembly 1110 thatconnects the handle assembly 1020 to the staple applying assembly 1016.During the staple firing motion, the firing bar 36 engages an elongatestaple channel 1060 and actuates a staple cartridge 42 containedtherein, both forming the lower jaw 1018 in the various mannersdescribed above.

A variety of different firing arrangements for applying an actuationforce to the firing bar 36 to cause the firing bar to linearly advanceand retract through the staple applying assembly 1016 are known. Suchfiring motions may be manually generated such as through use of thevarious firing system arrangements disclosed in U.S. patent applicationSer. No. 11/475,412, filed Jun. 27, 2006, entitled “Manually DrivenSurgical Cutting and Fastening Instrument” to Frederick E. Shelton, IV,et al., the disclosure of which is herein incorporated by reference.Still other actuation systems, such as the pneumatically poweredactuation systems disclosed in U.S. patent application Ser. No.11/497,868, filed Aug. 2, 2006, entitled “Pneumatically Powered SurgicalCutting and Fastening Instrument With a Variable Control of theActuating Rate of Firing With Mechanical Power Assist” to Frederick E.Shelton, IV et al., the disclosure of which is herein incorporated byreference may be successfully employed. Other embodiments may include,for example, the electrical motor driven actuation systems disclosed inU.S. patent application Ser. No. 11/343,562, filed Jan. 31, 2006,entitled “Motor-Driven Surgical Cutting and Fastening Instrument WithArticulatable End Effector” to Frederick E. Shelton, IV et al., thedisclosure of which is also herein incorporated by reference. Stillother embodiments may include other known mechanically, electrically,hydraulically and/or pneumatically powered firing systems withoutdeparting from the spirit and scope of the present invention.

In various embodiments, the elongate shaft assembly 1100 consists of aclosure tube assembly 1130 that is received on the spine assembly 1110.See FIG. 57. The spine assembly 1110 may comprise a single member or itmay comprise multiple segments with an articulation joint (not shown)mounted therein. Such articulation joints are known in the art and may,for example, be mechanically, electrically, hydraulically orpneumatically controlled. In the embodiment depicted in FIGS. 57 and 58,the spine assembly 1110 includes a proximal portion 1112 (FIG. 58) and adistal portion 1116 (FIG. 57). As will be discussed below, the proximalportion 1112 is attached to the handle assembly 1020 such that theclosure tube assembly 1130 may be axially moved thereon to cause theanvil 1050 to pivot between open and closed positions. As can be seen inFIG. 57, the elongate channel 1060 has proximally placed attachmentcavities 1062 that each receive a corresponding channel anchoring member1118 formed on the distal end of the distal spine portion 1116. Theelongate channel 1060 also has elongated anvil cam slots 1064 thatmovably receive a corresponding anvil trunnion 1052 on the anvil 1050 aswill be discussed in further detail below.

The closure tube assembly 1130 may comprise a distal closure tubeportion 1140 and a proximal closure tube portion 1150. The distalclosure tube portion 1140 and the proximal closure tube portion 1150 maybe fabricated from a polymer or other suitable material. The distalclosure tube portion 1140 and the proximal closure tube portion 1150 areeach hollow for receiving a corresponding portion of the spine assembly1110 therein. The closure tube assembly 1130 is depicted as comprisingtwo separate portions 1140 and 1150 for ease of assembly of the entireelongate shaft assembly 1100. Those portions 1140 and 1150 may beattached together after assembly by adhesive or other suitable fasteningmeans. It is conceivable, however, that the closure tube assembly 1130may be fabricated as one piece. In addition, as was mentioned above, thespine assembly of various embodiments of the present invention may havean articulation joint mounted therein. For those embodiments, a doublepivot closure joint (not shown) may be employed in the closure tubeassembly 1130. Examples of such double pivot closure arrangements aredisclosed in U.S. patent application Ser. No. 11/497,868, which has beenherein incorporated by reference.

In use, the closure tube assembly 1130 is translated distally to closethe anvil 1050, for example, in response to the actuation of the closuretrigger 1040. The anvil 1050 is closed by distally translating theclosure tube assembly 1130 on the spine assembly 1110, causing the backof a horseshoe aperture 1142 in the distal closure tube portion 1140 tostrike a closure feature 1053 in the form of an open/closing tab 1052 onthe anvil 1050 and cause it to pivot to the closed position. See FIG.57. To open the anvil 1050, the closure tube assembly 1130 is axiallymoved in the proximal direction on the spine assembly 1110 causing a tab1144 on the distal closure tube portion 1140 to contact and push againstthe open/closing tab 1054 on the anvil 1050 to pivot the anvil 1050 tothe opened position.

FIG. 58 illustrates an exploded assembly view of a non-limiting handleassembly 1020 of various embodiments of the present invention whereinthe various firing system components have been omitted for clarity. Inthe embodiment depicted in FIG. 58, the handle assembly 1020 has a“pistol grip” configuration and is formed from a right hand case member1022 and a left handed case member 1028 that are molded or otherwisefabricated from a polymer or other suitable material and are designed tomate together. Such case members 1022 and 1028 may be attached togetherby snap features, pegs and sockets molded or otherwise formed thereinand/or by adhesive, screws, bolts, clips, etc. The upper portion 1024 ofthe right hand case member 1022 mates with a corresponding upper portion1030 of the left hand case member 1028 to form a primary housing portiondesignated as 1031. Similarly, the lower grip portion 1025 of the righthand case member 1022 mates with the lower grip portion 1032 of the lefthand case member 1028 to form a grip portion generally designated as1034. See FIG. 56. Those of ordinary skill in the art will readilyappreciate, however, that the handle assembly 1020 may be provided in avariety of different shapes and sizes.

For the purposes of clarity, FIG. 58 only illustrates the componentsemployed to control the axial movement of the closure tube assembly 1130which ultimately controls the opening and closing of the anvil 1050. Ascan be seen in that Figure, a closure shuttle 1160 that is coupled tothe closure trigger 1040 by a linkage assembly 1180 is supported withinthe primary housing portion 1031. Closure shuttle 1160 may also befabricated in two pieces 1162, 1164 that are molded or otherwisefabricated from a polymer or other suitable material and are designed tomate together. For example, in the embodiment illustrated in FIGS. 58,60, and 61, the right hand portion 1162 may be provided with fastenerposts 1163 that are designed to be received within corresponding sockets1167 (FIG. 61) in the left hand portion 1164. The right and left handportions 1162, 1164 may be otherwise retained together by snap membersand/or adhesive and/or bolts, screws, clips, etc. As can be seen inthose Figures, a retention groove 1152 is provided in the proximal end1151 of the proximal closure tube portion 1150. The right hand portion1162 of the closure shuttle 1160 has a right retention flange 1165 (FIG.60) that is adapted to cooperate with a left hand portion 1164 of theclosure shuttle 1160 such that the retention flange 1165 extends intothe retention groove 1151 in the proximal closure tube portion 1150. Theretention flange 1165 serves to affix the closure tube assembly 1130 tothe closure shuttle 1160 while facilitating its limited axial movementrelative thereto as will be discussed in further detail below.

As can also be seen in FIG. 58, a right spine assembly retention peg1027 protrudes inward from the right hand case member 1024. Such peg1027 protrudes into an elongated slot or window 1166 in the right handportion 1162 of the closure shuttle 1160. A similar closure shuttleretention peg (not shown) protrudes inward from the left hand casemember 1164 to be received in another window or slot 1168 provided inthe left hand side portion 1164 of the closure shuttle 1160. Theretention pegs are configured to extend into a hole 1115 in the proximalend 1114 of the proximal spine portion 1110 to non-movably affix thespine portion 1110 to the handle assembly 1020 while permitting theclosure shuttle 1160 to move axially relative thereto. See FIG. 58. Theretention pegs may be mechanically attached to the proximal end 1114 ofthe proximal spine portion 1112 by, for example, bolts, screws,adhesive, snap features, etc. In addition, the closure shuttle 1160 isprovided with laterally extending guide rails 1170, 1172. Rail 1170 isconfigured to be slidably received within rail guide 1026 in the righthand case member 1024 and rail 1172 is configured to be slidablyreceived within a rail guide (not shown) in left hand case member 1028.See FIG. 58.

Axial movement of the closure shuttle 1160 and closure tube assembly1130 in the distal direction (arrow “A”) is created by moving theclosure trigger 1040 toward the grip portion 1034 of the handle assembly1020 and axial movement of the closure shuttle 1160 in the proximaldirection (arrow “B”) is created by moving the closure trigger 1040 awayfrom the grip portion 1034. In various embodiments, the closure shuttle1160 is provided with a connector tab 1174 that facilitates theattachment of the closure linkage assembly 1180 thereto. See FIGS. 58and 59. The closure linkage assembly 1180 includes a yoke portion 1182that is pivotally pinned to the connector tab 1174 by a pin 1184. Theclosure linkage assembly 1180 further has a closure arm 1186 that ispivotally pinned to a yoke assembly 1043 formed on the closure trigger1042 by a closure pin 1188 as illustrated in FIG. 58. The closuretrigger 1140 is pivotally mounted within the handle assembly 1020 by apivot pin 11890 that extends between the right hand case member 1024 andthe left hand case member 1028.

When the clinician desires to close the anvil 1050 to clamp tissuewithin the end effector 1014, the clinician draws the closure trigger1040 toward the pistol grip portion 1034. As the clinician draws theclosure trigger 1040 toward the pistol grip portion 1034, the closurelinkage assembly 1180 moves the closure shuttle 1160 in the distal “A”direction until the closure linkage assembly 1180 moves into the lockedposition illustrated in FIG. 59. When in that position, the closurelinkage assembly 1180 will tend to retain the closure shuttle 1160 inthat locked position.

In various embodiments, to further retain the closure shuttle 1160 inthe closed position, the closure trigger 1040 may be provided with areleasable locking mechanism 1190 that is adapted to engage the pistolgrip portion 1034 and releasably retain the closure trigger 1040 in thelocked position. Other locking devices may also be used to releasablyretain the closure shuttle 1160 in the locked position.

In the embodiment depicted in FIG. 59, the closure trigger 1040 includesa flexible longitudinal arm 1192 that includes a lateral pin 1194extending therefrom. The arm 1192 and pin 1194 may be made from moldedplastic, for example. The pistol grip portion 1034 of the handleassembly 1020 includes an opening 1036 with a laterally extending wedge1037 disposed therein. When the closure trigger 1040 is retracted, thepin 1194 engages the wedge 1037, and the pin 1194 is forced downward(i.e., the arm 1192 is rotated clockwise) by the lower surface of thewedge 1037. When the pin 1194 fully passes the lower surface, theclockwise force on the arm 1192 is removed, and the pin 1194 is rotatedcounterclockwise such that the pin 1194 comes to rest in a notch 1038behind the wedge 1037 thereby locking the closure trigger 1040. The pin1194 is further held in place in the locked position by a flexible stop1039 extending from the wedge 1037.

To unlock the closure trigger 1040, the operator may further squeeze theclosure trigger 1040, causing the pin 1194 to engage a sloped back wall1041 of the opening 1036, forcing the pin 1194 upward past the flexiblestop 1039. The pin 1194 is then free to travel out of the opening 1036such that the closure trigger 1040 is no longer locked to the pistolgrip portion 1034. Further details of such arrangement may be found inU.S. patent application Ser. No. 11/344,020, filed Jan. 31, 2006 andentitled “Surgical Instrument Having A Removable Battery to Shelton, IVet al.,” the relevant portions of which are herein incorporated byreference. Other releasable locking arrangements could also be employed.

As the closure shuttle 1160 is moved to the locked position, the closuretube assembly 1130 is moved distally on the spine assembly 1110 causingthe closure/opening tab 1054 on the anvil 1050 to be contacted by theproximal end of the horseshoe aperture 1142 in the distal closure tubeportion 1140 to thereby pivot the anvil 1050 to the closed (clamped)position. Thus, the clamping forces attained by the anvil 1050 duringthe clamping process are ultimately dependant upon the closure forcesgenerated by the closure tube assembly (represented by arrow 1196 inFIGS. 62 and 63) as it contacts the tab 1054 on the anvil 1050. As wasdiscussed above, prior closure tube arrangements lack means for limitingthe amount of actuation force applied to the closure/opening tab 1054 ofthe anvil 1050.

Various embodiments of the present invention address such shortcomingsof prior closure tube arrangements by including a force limiting membergenerally designated as 1200 for limiting the amount of closure force orload applied by the closure tube assembly to the closure/opening tab1054 of the anvil. For example, in one embodiment, the force limitingmember 1200 may comprise a cushioning member 1210 oriented adjacent tothe proximal end 1151 of the proximal closure tube portion 1150. Morespecifically and with reference to FIGS. 60 and 61, the cushioningmember 1210 comprises a wave spring assembly 1212 that may be supportedin a cavity 1169 formed in the closure shuttle 1160. The wave springassembly 1212 may be supported between an attachment post 1163 and theproximal end 1151 of the proximal closure tube portion 1150. In variousembodiments, the wave spring assembly 1212 may be fabricated from springsteel in the form depicted in the Figures. However, other cushioningarrangements or compliant member arrangements such as, for example,members fabricated from rubber, elastomer, polymer, foam rubber, etc.could be successfully employed to provided the closure tube assembly1130 with some freedom to axially move in the proximal direction toreduce the clamping force ultimately applied to the anvil 1050 duringthe anvil closing process which will be discussed in further detailbelow.

As can also be seen in FIGS. 60 and 61, the retention groove 1152 in theproximal closure tube portion 1150 comprises an area 1154 that has adiameter that is less than the outer diameter of the proximal closuretube portion 1150. The area 1154 is axially elongated to provide theclosure tube assembly 1130 to move axially and distally relative to theclosure shuttle 1160 a distance that is defined by the axial length(arrow 1155 in FIG. 60) of the retention groove 1152.

In this embodiment, as the closure trigger 1040 is moved toward thepistol grip portion 1032, the closure shuttle 1160 is advanced in thedistal direction (arrow A). As the closure shuttle 1160 moves distally,the closure tube assembly 1130 is also forced distally. As can be seenin FIGS. 62 and 63, distal end 1141 of the distal closure tube portion1140 is oriented to move axially up a ramp portion 1070 of the anvil1050. As the distal end 1141 contacts the anvil ramp 1070 and continuesto move distally up the ramp, it imparts a closure force to the anvil1050. The anvil trunnions 1052 are received in corresponding“kidney-shaped” slots 1064 in the proximal end of the elongate staplechannel 1060 and serve to guide the anvil 1050 in a desired closure pathwhich results in the clamping of the tissue between the staple formingundersurface of the anvil 1051 and the upper surface of the staplecartridge 42. As the anvil 1050 contacts the tissue, a resultingresistive force is transferred to the anvil 1050 and ultimately to thedistal end 1141 of the distal closure tube portion 1140. The magnitudeof such resistive force is effected by the thickness of the tissue beingclamped. Thinner tissues will exert less resistive forces than thickertissues. However, as the resistive forces are encountered, thecushioning member 1210 enables the closure tube assembly 1130 to moveproximally to ultimately limit the amount of closure force applied tothe anvil 1050 by the closure tube assembly 1130.

The magnitudes of the resistive forces for various thicknesses and typesof tissues may be determined and the wave spring 1212 sized accordinglysuch that the desired amount of clamping force is applied to the tissuebetween the anvil 1050 and the staple cartridge 42. The wave spring 1212may be sized and oriented such that when the anvil 1050 is at a fullycompressed position, the wave spring 1212 is not fully compressed or“bottomed out”.

FIGS. 64 and 65 illustrate other versions of closure tube assembliesthat may be employed to limit closure forces applied to the anvil 1050.As can be seen in those Figures, the force limiting members 1200 a, 1200b comprise spring sections 1212 a, 1212 b actually formed into thedistal closure tube portion 1140 a, 1140 b, respectively. While thespring sections 1140 a, 1140 b are depicted as being somewhat helical innature and formed in the distal closure tube portions 1140 a, 1140 b,those of ordinary skill in the art will understand that the springsections 1212 a, 1212 b may be provided in any portion of the closuretube assemblies 1130 a, 1130 b and could conceivable be provided indifferent configurations. Those of ordinary skill in the art willunderstand that in these embodiments, the retention groove 1152 in theproximal closure tube portion may not be elongated such that the closuretube assembly 1130 a, 1130 b is essentially not axially movable relativeto the closure shuttle 1160. In addition, while only one spring sectionis shown as being provided in the closure tube assembly, it isconceivable that more than one spring section may be formed in a singleclosure tube assembly. As with the above-described versions, as theresistive forces are encountered during clamping, the spring members1212 a, 1212 b enable their respective closure tube assembly 1130 a,1130 b to move proximally to ultimately limit the amount of closureforce applied to the anvil 1050.

FIGS. 66 and 67 illustrate another closure tube assembly of variousembodiments of the present invention that may be employed to limitclosure forces applied to the anvil 1050. As can be seen in thoseFigures, the force limiting member 1200 c comprises a leaf spring 1212 cformed in the distal end 1141 of the distal closure tube portion 1140 c.When the closure tube assembly 1130 c is actuated to move distally toclose the anvil 1050, the leaf spring 1212 c rides up the anvil ramp1070 and is free to move radially (arrows 1214 in FIG. 66) and axially(arrow 1216 in FIG.). As with the above-described versions, as theresistive forces are encountered during clamping, the leaf spring 1212 cenables the closure tube assembly 1130 c to move proximally (arrow B) toultimately limit the amount of closure force applied to the anvil 1050.

FIGS. 68 and 69 illustrate another embodiment of the present inventionthat may be employed to limit closure forces applied to the anvil 1050by the closure tube assembly 1130. As can be seen in those Figures, thisembodiment employs an anvil 1050 d that has a stepped ramp 1070 that isconfigured to be engaged by the distal end 1141 of the distal closuretube portion 1140. In particular, the anvil 1050 d depicted in thoseFigures has a series of steps 1074 d, 1076 d, 1078 d, 1080 d formedtherein. As the closure tube assembly 1130 is moved distally, the distalend 1141 starts to ride up the smooth portion 1072 d of the ramp 1070until it contacts the first step 1074 d. The closure tube assembly 1130will not advance further up the ramp 1070 d to apply a higher amount ofclosure force to the anvil until the actuation force applied to theclosure tube assembly 1130 attains a sufficient magnitude to cause thedistal end 1141 to bump up over the first step 1074 d and proceed toengage the next step 1076 d. The closure tube assembly 1130 will notadvance further up the ramp 1070 d until the actuation force attains asufficient magnitude to cause the distal end 1141 to bump up over thesecond step 1076 d at which time it will engage the next step 1078 d andso on. Thus, the stepped anvil 1050 d cooperates with the closure tubeassembly 1130 to provide a means for relating the amount of clampingforces ultimately applied to the tissue between the anvil 1050 d and thestaple cartridge 42 based on the amount of resistive forces generatedthereby and encountered by the closure tube assembly 1130 duringclamping. While four such steps have been disclosed, other numbers ofsteps may be employed. For example, only one such step may be used or 2,3, or more than 4 steps could conceivably be employed.

FIGS. 70-76 illustrate another unique and novel endocutter implementportion 1014 e of various embodiments of the present invention thatincludes an elongate channel 1060 e and an anvil arrangement 1050 e thatare “self adjusting” with respect to tissue thickness. In variousembodiments, the proximal end of the anvil 1050 e is pivotally attachedto the proximal end of the elongate channel 1060 e by mounting memberswhich may comprise trunnions 1052 e movably received in correspondingelongate slots 1064 e formed in the proximal end 1061 e of the elongatechannel 1060 e. As can be seen in FIGS. 70-74, at least one of the slots1064 e on each side of the elongate channel 1060 e (only one slot 1064 eis illustrated in FIGS. 70-74) and preferably both of the slots 1064 eeach have an end wall 1065 e that has a discrete number of predeterminedlocations in the form of detents or pivot nests 1066 e, 1067 e, 1068 e,1069 e formed therein. As can be seen in these Figures, the detents 1066e, 1067 e, 1068 e, 1069 e may each comprise a V-shaped notch that isadapted to seatingly receive the pointed end of a pawl 1080 e formed onthe corresponding trunnion 1052 e. It is conceivable that other detentand pawl configurations may be successfully employed. As can also beseen in FIGS. 70-74, this embodiment may further include a leaf spring1090 or other suitable biasing member for applying a downward biasingforce to the proximal end 1055 e of the anvil 1050 e. In variousembodiments, the leaf spring 1090 may be attached to the distal portion1116 of the spine assembly 1110 and oriented to bear upon the proximalend 1055 e of the anvil 1050 e.

As can be seen in FIG. 74, the slot 1064 e is sized relative to thetrunnion 1052 e to permit the trunnion 1052 e to find different clampedheights in response to the thickness of the tissue clamped between theanvil 1050 e and the cartridge 42 and the application of the closingmotion to the anvil 1050 e. The leaf spring 1090 serves to bias the pawl1080 e into a slightly upward position wherein it can be received in anyone of the notches 1066 e, 1067 e, 1068 e, 1069 e. As the anvil 1050 eis closed onto the tissue by means of distally advancing the closuretube assembly 1130 in the above-described manner, the tissue thicknessitself may dictate which of the notches 1066 e, 1067 e, 1068 e, 1069 ethat the pawl 1080 ultimately seatingly engages. Because the leaf spring1090 biases the pointed pawl upwardly, the pawl 1080 would find theuppermost notch 1069 e when no tissue is between the anvil 1050 e andthe cartridge 42 which would clamp the end effector 1014 e to is mostclosed position. See FIGS. 71 and 74. However, if during the clampingprocess, the anvil 1050 e and channel 1060 e encounter resistance, theleaf spring 1090 would be compressed and the anvil trunnions 1052 ewould find a lower pivot notch which would ultimately result in a largergap between the anvil 1050 e and the cartridge 42.

FIG. 70 illustrates the anvil 1050 e in an open position. FIG. 71illustrates the anvil 1050 e in its most closed position. The tissueclamping space or distance between the underside 1051 e of the anvil1050 e and the cartridge 42 is designated as “t”. FIG. 75 alsoillustrates the position of the anvil 1050 e relative to the staplecartridge 42 and tissue 1092 that has a thickness “t”. Similarly, FIG.73 illustrates the anvil 1050 e in its uppermost clamped positionwherein the distance between the underside 1051 e of the anvil 1050 eand the cartridge 42 is designated as “T”. FIG. 76 also illustrates theanvil 1050 e relative to the staple cartridge 42 and tissue 1094 thathas a thickness “T”. As can be seen in FIGS. 75 and 76, the staples 83in the thinner tissue 1092 are more tightly formed than the staples 83extending through the thicker tissue 1094.

FIGS. 77-88 illustrate another embodiment of the present invention thatmay be employed in connection with a circular stapler 1600 that includesa unique and novel apparatus for limiting the amount of compressionforce that can be generated between the anvil and the staple cartridgeto avoid over compressing and possibly destroying the tissue to bestapled. A variety of different circular staplers are known in the art.FIGS. 77-88 illustrate an exemplary circular stapler arrangement thatmay employ the benefits of various aspects of the subject invention. Itis conceivable, however, that the various embodiments of the presentinvention may be successfully employed with other stapler constructionswithout departing from the spirit and scope of the present invention.

As seen in FIG. 77, there is disclosed the circular stapler 1600includes a head 1610, an anvil 1700, an adjustment knob assembly 1800,and trigger 1664. The head 1610 is coupled to a handle assembly 1660 byan arcuate shaft assembly 1630. The trigger 1664 is pivotally supportedby the handle assembly 1660 and acts to operate the stapler 1600 when asafety mechanism 1670 is released. As will be discussed in furtherdetail below, when the trigger 1664 is activated, a firing mechanism(not shown in FIG. 77) operates within the shaft assembly 1630 so thatstaples 1618 are expelled from the head 1610 into forming contact withthe anvil 1700. Simultaneously, a knife 1620 operably supported withinthe head 1610 acts to cut tissue held within the circumference of thestapled tissue. The stapler 1600 is then pulled through the tissueleaving stapled tissue in its place.

FIG. 78 illustrates one form of anvil 1700 and head 1610 that may beemployed in connection with various embodiments of the subjectinvention. As can be seen in that Figure, the anvil 1700 may have acircular body portion 1702 that has an anvil shaft for attaching atrocar thereto. The anvil body 1702 has a staple forming undersurface1706 thereon and may also have a shroud 1708 attached to the distal endthereof. The anvil 1700 may be further provided with a pair of trocarretaining clips or leaf-type springs 1710 that serve to releasablyretain a trocar 1644 in retaining engagement with the anvil shaft 1704as will be discussed in further detail below. In the embodiment depictedin FIG. 78, a plastic knife board 1714 may be fitted into a cavity 1712in the anvil body 1702.

As can also be seen in FIG. 78, the head 1610 may comprise a casingmember 1612 that supports a cartridge supporting assembly in the form ofa circular staple driver assembly 1614 therein that is adapted tointerface with a circular staple cartridge 1616 and drive staples 1618supported therein into forming contact with the staple formingundersurface 1706 of anvil 1700. A circular knife member 1620 is alsocentrally disposed within the staple driver assembly 1614. The proximalend of the casing member 1612 may be coupled to an outer tubular shroud1631 of the arcuate shaft assembly 1630 by a distal ferrule member 1632.

FIGS. 79-82 illustrate one form of arcuate shaft assembly 1630 that maybe employed with various embodiments of the present invention. As can beseen in FIGS. 79 and 80, the arcuate shaft assembly 1630 may include acompression shaft 1634, a distal compression shaft portion 1635, a toptension band 1636, a bottom tension band 1638 and a spacer band 1640that are assembled within the outer tubular shroud 1631 (FIG. 80). Atrocar tip 1644 may be attached to the top tension band 1636 and bottomtension band 1638 by fasteners 1646. The proximal ends of the toptension band 1636 and bottom tension band 1638 may be attached to adistal end of an adjustment shaft 1650. As can be seen in FIG. 80, thetrocar tip 1644 may be inserted into the anvil shaft 1704 of the anvil1700 and retained in engagement by trocar retaining clips 1710.

As can be seen in FIG. 80, the distal compression shaft portion 1635 iscoupled to the staple driver assembly 1614. Thus, axial movement of thecompression shaft 1634 within the outer tubular shroud 1631 causes thestaple driver assembly 1614 to move axially within the casing member1612. As will be discussed below, actuation of the firing trigger 1664will cause the compression shaft 1634 to move in the distal direction(arrow “DD”) thereby driving the staple driver assembly 1614 distally tofire the staples 1618 into forming contact with the staple formingundersurface 1706 of the anvil 1700. As the staple driver assembly 1614is driven distally, it also drives the distal end 1622 of the knife 1620through the tissue held within the circumference of the stapled tissueinto the knife board 1714 mounted in the anvil 1700. The knife board1714 may be fabricated from plastic or other suitable material that willpermit the sharp distal end 1622 of the knife 1620 to penetrate andachieve a desirable cutting action through the clamped tissue.

In various embodiments, the adjusting shaft 1650 is axially movablysupported within a handle assembly 1660 that may comprise two handlecasing segments 1661, 1662 that are interconnected together by suitablefastener arrangements for ease of assembly. The trigger 1664 ispivotally attached to the handle assembly 1660 by a pivot pin 1666. Aspring 1668 is supported on pivot pin 1666 and serves to bias thetrigger 1664 away from the handle assembly 1660 to an unactuatedposition. A safety yoke 1670 is pivotally coupled to the triggerassembly 1664 by pin 1672 such that it can be pivoted between a safeposition wherein the trigger 1664 cannot be depressed towards the handle1660 and an off position wherein the safety yoke 1670 does not inhibitpivotal travel of the trigger assembly 1664 toward the handle assembly1660. As can be seen in FIG. 79, the trigger 1664 may have a pair offins 1665 that are sized to be received in slots 1676 in a firing clip1674 that is attached to the proximal end 1637 of compression shaft 1634by a protrusion 1639 or other suitable fastener arrangements. Sucharrangement permits the distal axial movement (arrow “DD”) and theproximal axial movement (arrow “PD”) of the compression shaft 1634 bypivoting the trigger 1664 as will be further discussed below. Thetrigger 1664, the compression shaft portions 1634, 1635 and the firingcap 1674 and other related components may comprise a firing assemblygenerally designated as 1675.

As can be seen in FIGS. 79 and 81, the adjustment shaft 1650 has adistal portion 1651 that is attached to the top and bottom tension bands1636, 1638 and a proximal portion 1652 that is adjoined to the distalportion 1651 by a reduced diameter segment 1653. The proximal portion1652 is axially received within an axial passage 1722 in the distalclosure nut 1720 that is keyed onto or otherwise attached to a proximalclosure nut 1740 to form a closure nut assembly generally designated as1721 such that the distal closure nut 1720 and the proximal closure nut1740 may rotate together. The distal closure nut 1720 may further have adistally extending hub portion 1724 that abuts an inwardly extendingretainer flange 1667 formed inside the handle assembly 1660. See FIG.81. Such arrangement permits the distal closure nut 1720 to freelyrotate within the handle assembly 1660, but is unable to move axiallytherewithin. Likewise, the proximal end portion 1652 of the adjustmentshaft 1650 is axially received within an axial passage 1742 within theproximal closure nut 1740. A circumferentially extending groove 1744 maybe provided in the outer surface of the proximal closure nut 1740 forreceiving an inwardly protruding proximal retainer flange 1669 formed onthe proximal end of the handle assembly 1660. Such arrangement serves topermit the proximal closure nut 1740 to freely rotate relative to thehandle assembly 1660.

Also in various embodiments, the closure knob assembly 1800 is attachedto the proximal end 1741 of the proximal closure nut 1740. In oneembodiment for example, the proximal end 1741 of the proximal closurenut 1740 may be formed with a proximally extending tapered hub portion1746 that is adapted to be nonrotatably received in an axial passage1832 in a clutch hub portion 1830. See FIG. 81. The tapered hub portion1746 also be formed with a key or spline arrangement to non-rotatablyaffix the hub portion 1746 with the clutch hub portion 1830. Otherfastener arrangements and methods may be employed to non-movably attachthe hub portion 1746 of the proximal closure nut 1740 to the clutch hubportion 1830. Thus, rotation of the clutch hub portion 1830 will causethe proximal closure nut 1740 and distal closure nut 1720 to alsorotate.

As can also be seen in FIGS. 81, 83, and 84, the knob assembly 1800 mayfurther include a proximal cap portion 1810 and a distal cap portion1820. The proximal end 1831 of the clutch hub portion may be received ina circular slot 1814 formed in a distal end of the proximal cap portion1810. The slot 1814 may be sized to permit the proximal cap portion 1810to rotate about the proximal end 1831 of the clutch hub portion 1830. Inaddition, the proximal cap portion 1810 may have a protrusion 1812 thatrotatably extends into the axial passage 1832 in the clutch hub portion1830. Also in various embodiments, the closure knob assembly 1800 maycomprise a distal cap portion 1820 that is rigidly and non-rotatablycoupled to the proximal cap portion 1810. Those of ordinary skill in theart will understand that the closure knob assembly 1800 may befabricated in multiple parts for ease of assembly of various componentsof the instrument. In various embodiments, the mating ends of theproximal cap portion 1810 and distal cap portion 1820 may be configuredwith complementary flanged portions 1813, 1823, respectively as shown inFIGS. 81 and 83, that are interconnected by adhesive, welding, etc. orother fastener arrangements may be employed. Thus, when fastenedtogether, the proximal cap portion 1810 and the distal cap portion 1820rotate together as a unit.

As can further be seen in FIGS. 81 and 83, various embodiments maycomprise a slip clutch assembly generally designated as 1821. The slipclutch assembly 1821 may take various forms that are supported by or areintegrally formed in the adjustment knob assembly 1800. In oneembodiment, for example, the distal cap portion 1820 may be providedwith an inwardly extending cap flange 1824 that is in confrontingorientation with an outwardly extending clutch flange 1834 formed on theclutch hub portion 1830. A first friction pad 1840 is non-rotatablyaffixed to the inwardly extending cap flange 1824. A pad cavity 1836 maybe formed within the clutch flange 1834 for movably receiving a secondfriction pad 1850 and a wave spring 1852 therein. The second frictionpad 1850 may be provided with splines or keys (not shown) to preventrotation thereof in the cavity 1836, but facilitate some axial travelthereof within the cavity 1836. In various embodiments, the first andsecond friction pads 1840, 1850 may be fabricated from, for example,liquid crystal polymer, Nylon, ULTEM®, polycarbonate, aluminum, etc.

In various embodiments, the proximal portion 1652 of the adjustmentshaft 1650 has a low pitch thread segment 1654 formed therein thatcommunicates with a higher pitched threaded segment 1657. See FIG. 79.As can be seen in FIG. 81, a drive pin 1726 protrudes inwardly into theaxial passage 1722 for “driving” engagement with the threaded segments1654, 1657 in the adjustment shaft 1650. In addition, the proximal end1652 of the adjustment shaft 1650 has a threaded section 1658 adaptedfor threaded engagement with a threaded cavity 1748 in the tapered hubportion 1746 of the proximal closure nut 1740. In various embodiments,the drive pin 1726 is oriented in the distal closure nut 1720 such thatwhen the drive pin 1726 is still engaged with the low pitched distalthread segment 1654 of the adjustment shaft 1650, the threaded end 1658of the adjustment shaft 1650 has sufficiently threadedly engaged thethreaded cavity 1748 in the tapered hub portion 1746 of the proximalclosure nut 1740 for threaded travel therein as the closure knobassembly 1800 is rotated. In particular, as the closure knob assembly1800 is rotated in the counterclockwise (“CC”) direction, the adjustmentshaft 1650 is moved in the distal direction “DD” by virtue of theengagement of the drive pin 1726 with the threaded segments 1654 and1657 formed in the attachment rod 1650. Those of ordinary skill in theart will appreciate that rotation of the distal closure nut 1720 whenthe drive pin 1726 is engaged with the distal threaded segment 1654 willresult in fastener axial movement of the adjustment shaft 1650 than whenthe drive rod 1726 is engaged with the threaded segment 1567 which has alarger pitch than the threaded segment 1564. Axial movement of theadjustment shaft 1650 moves the top and bottom tension bands 1636, 1638,the trocar tip 1644 and the anvil 1700 (when attached to the trocar tip1644) in the distal “DD” direction away from the head 1610.

To close the anvil 1700 or move it toward the head 1610 and staplecartridge 1616 supported therein in the “PD direction, the surgeonbegins to turn the closure knob assembly 1800 in the clockwise (“CW”)direction. The frictional forces generated between the first and secondfriction pads 1840, 1850 serves to retain the closure knob assembly 1800in frictional engagement with the clutch hub 1830 which is non-rotatablyattached to the proximal closure nut 1740. Because the proximal closurenut 1740 is non-rotatably affixed to the distal closure nut 1720, thedistal closure nut 1720 is also rotated in the clockwise direction.Rotation of the distal closure nut 1720 results in the drivingengagement of the drive pin 1726 with either of the thread segments1654, 1657 (depending upon the position of the adjustment shaft 1650relative thereto) and causes the adjustment shaft 1650 to be drawn inthe proximal direction (“PD”). As the adjustment shaft 1650 is drawn inthe proximal direction, the threaded end 1658 of the adjustment shaft1650 threadably engages the threaded cavity 1748 of the tapered threadedhub portion 1746 of the proximal closure nut 1740 and reduced diametersegment 1653 moves adjacent to the drive pin such that the drive pin isno longer in driving engagement with the adjustment shaft 1650. Now, thethreaded end 1652 is in full threaded engagement with the threaded hole1748 in the proximal closure nut 1740. Further rotation of the closureknob assembly 1800 in the clockwise direction continues to draw theadjustment shaft 1650 in the proximal direction “PD”. As the adjustmentshaft 1650 is drawn in the proximal direction, the anvil 1700 is movedtowards the cartridge 1616 supported in the staple driver assembly 1614to clamp an amount of tissue therebetween. As the anvil 1700 continuesto move toward the staple cartridge 1616, the tissue is compressedtherebetween and resists further travel of the anvil 1700 in theproximal direction.

In various embodiments, to prevent the tissue from being over compressedwhich could result in damaging or killing the tissue to be stapled, thecomposition of the first and second friction pads 1840, 1850 and thesize of the spring 1852 are selected such that when a predeterminedamount of tissue compression is attained, the friction pads 1840, 1850begin to slip to prevent further rotation of the closure knob assembly1800 from being transferred to the clutch hub 1830. Thus, even if thesurgeon continues to rotate the closure knob assembly 1800 after thetissue has been adequately compressed, such further rotation will notresult in continued movement of the adjustment shaft 1650 (and anvil1700) in the proximal direction to avoid over compressing the tissue.For example, in various embodiments, the instrument may be constructedsuch that the maximum amount of compression forces that may be appliedto the tissue between the anvil 1700 and the cartridge 1616 may beapproximately 150 pounds per square inch. For such applications, thefirst and second friction pads 1840, 1850 and the wave spring 1852 maybe so configured to permit slippage between the first and secondfriction pads 1840, 1850 if the closure knob assembly 1800 continues tobe rotated after that maximum amount of compression force has beenattained. In such example, the rotation of the closure knob assembly1800 may generate an approximate amount of torque of, for example, 15inch pounds which overcomes the frictional forces that are establishedwhen the maximum amount of desirable compression has been attained(which serves to retain the first and second friction pads 1840, 1850 infrictional engagement with each other) and permit the desired slippagebetween the first and second friction pads. In various embodiments, toensure that the adjustment shaft 1650 is moved distally when the closureknob assembly 1800 is rotated in a counterclockwise direction, a seriesof circumferentially extending ratchet teeth 1816 may be formed in theinterior of the closure knob assembly 1800 for engagement withcircumferentially extending engagement teeth 1835 formed on thecircumference of the clutch flange 1834. See FIGS. 83 and 84. The teeth1816, 1835 may be configured such that when the closure knob assembly1800 is rotated in the clockwise direction to move the anvil 1700 towardthe cartridge 1616, the teeth 1816 on the closure knob assembly 1800slip over the teeth 1835 formed on the clutch flange 1834. However, whenthe closure knob assembly 1800 is rotated in the counterclockwisedirection, the teeth 1816 engage teeth 1845 on the clutch flange 1834 tocause the clutch hub 1830 and the proximal and distal closure nuts 1720,1740 to rotate therewith to move the anvil 1700 away from the cartridge1616.

As indicated above, various embodiments may be provided with a safetyyoke 1670 that prevents actuation of the trigger assembly 1664 when thesafety yoke 1670 is in a “safe” or engaged position. In variousembodiments, a safety spring 1686 may be journaled on the adjustmentshaft 1650 and be received on the hub portion 1724 of the distal closurenut 1720. The spring 1686 may be oriented between the distal closure nut1720 and an upstanding end wall portion 1688 of the safety release 1684.See FIG. 81. The safety spring 1686 serves to bias the safety release1684 in the distal direction and into contact with the safety yoke 1670to prevent the safety yoke from being pivoted to an off position whereinthe trigger 1664 may be actuated. Also in these variations, a rod clip1690 may be attached to the adjustment shaft 1650 by and adjusting screw1692 that extends through a slot (not shown) in the rod clip 1690. Therod clip 1690 may be so located on the adjustment shaft 1650 such thatwhen the adjustment shaft 1650 has been axially positioned in its mostproximal position which results in the maximum amount of desirablecompression being applied to the tissue or in a position wherein theanvil 1700 has begun to clamp the tissue, but has not yet attained thepredetermined maximum amount of compression force, the rod clip 1690 hascontacted the upstanding end wall 1688 and moved it proximally asufficient distance to move the distal end 1685 of the safety release1684 out of retaining engagement with the safety yoke 1670. The surgeonmay then pivot the safety yoke 1670 to the off position thereby enablingthe trigger 1664 to be depressed.

Various embodiments of the invention may also be fitted with a stapleform indicator 1676 that may be pivotally mounted within the handleassembly 1660 by a pivot pin 1678. The staple form indicator 1676 mayhave a pointer end portion 1679 that is viewable through a viewingwindow 1663 (FIG. 77) formed in the handle assembly 1660. The endportion 1679 may be biased in the distal direction by an indicatorspring 1680. As can be seen in FIG. 79, the staple form indicator 1676may be formed with a tab 1682 that is oriented for engagement by ahooked end 1685 of a safety release 1684. As the safety release 1684 ismoved proximally in connection with the proximal movement of theadjustment shaft 1650, the hooked end 1685 causes the staple formindicator 1676 to pivot in the proximal direction. An indicator plate(not shown) may be positioned within the window 1663 and so calibratedsuch the indicator 1676 cooperates with the indicator plate to indicatethe amount of distance between the anvil 1700 and the cartridge 1616.

One exemplary method of using the circular stapler 1600 will now bedescribed with reference to FIGS. 85-88. When performing an anastomosisusing a circular stapler, the intestine 1900 may be stapled using aconventional surgical stapler with multiple rows of staples beingemplaced on either side of a target section (i.e., specimen) ofintestine 1900. FIG. 85 illustrates the liner staple lines 1910, 1920.The target section is typically simultaneously cut as the section isstapled. The target section has already been removed in FIG. 85. Next,after removing the target specimen, the surgeon inserts the anvil 1700into the proximal portion 1902 of the intestine 1900, proximal of thestaple line 1910. This is done by inserting the anvil head 1700 into anentry port cut into the proximal intestine portion 1902 or the anvil1700 can be placed transanally, by placing the anvil 1700 on the distalend of the stapler 1600 and inserting the instrument through the rectum.Next, the surgeon attaches the anvil 1700 to the trocar tip 1644 of thestapler 1600 and inserts the anvil 1700 into the distal portion 1906 ofthe intestine 1900. The surgeon may then tie the distal end 1904 of theproximal section 1902 of the intestine 1900 to the anvil shaft 1704using a suture 1912 or other conventional tying device and also tie theproximal end 1908 of the distal intestine portion 1906 around the anvilshaft using another suture 1914. See FIG. 86. The surgeon then begins torotate the closure knob assembly 1800 in the clockwise direction to drawthe anvil 1700 toward the cartridge 1616 supported in the staple driver1614 to close the gap between the anvil 1700 and cartridge 1616 andthereby engage the proximal end 1908 of the distal intestine portion1906 with the distal end 1904 of the proximal intestine portion 1902 inthe gap “G” therebetween. See FIG. 87. The surgeon continues to rotatethe closure knob assembly 1800 until the first and second friction pads1840, 1850 slip and the desired amount of compression (the desired gapG) is attained. When in that position, the surgeon may then pivot thesafety yoke 1670 to the off position and fire the stapler 1600 bydepressing the firing trigger 1664. Depressing the trigger 16614 causesthe compression shaft 1634 to drive the staple driver 1614 distally todrive the staples 1618 to be driven through both ends 1904, 1908 of theintestine 1900, thereby joining the portions 1902 and 1906 and forming atubular pathway. Simultaneously, as the staples 1618 are driven andformed, the knife 1620 is driven through the intestinal tissue ends 1904and 1908, cutting the ends adjacent to the inner row of staples 1618.The surgeon then withdraws the stapler 1600 from the intestine and theanastomosis is complete.

FIGS. 89-95 illustrate another stapler embodiment 1600 a of the presentinvention. Stapler 1600 a may essentially employ the same componentsdescribed above with respect to stapler 1600 except for the changes thatwill be discussed in detail below. For example, in this embodiment, aslip clutch assembly may not be employed. However, this embodiment mayemploy a closure actuator assembly 2000 that includes a proximal capportion 2010 and a distal cap portion 2040 that are rotatably retainedtogether.

More specifically, as shown in FIGS. 90 and 91, in various embodiments,the proximal cap portion 2010 may have a sleeve portion 2012 that issized to extend over the outer wall portion 2044 of the distal capportion 2040 and be retained thereon by virtue of an inwardly extendingflange 2014 formed on the sleeve portion 2012. Flange 2014 may besnapped over an outwardly protruding rim 2046 formed on thecircumference of the wall portion 2044 of the distal cap portion 2020.Such arrangement serves to attach the proximal cap portion 2010 to thedistal cap portion 2040 while facilitating its rotation relativethereto. To facilitate ease of attachment, a beveled edge 2048 may beprovide on the end 2041 of the wall portion 2044.

As can also be seen in FIGS. 90 and 91, the distal cap portion 2040 mayfurther have a cap hub portion 2050 that has a proximal end 2052 thatmay be rotatably received in a circular slot 2016 formed in the proximalcap portion 2010. The slot 2016 may be sized relative to the cap hubportion 2050 such that the proximal cap portion 2010 can freely rotatearound the cap hub portion 2050. In addition, the proximal cap portion2010 may have a protrusion 2018 that rotatably extends into an axialpassage 2054 in the cap hub portion 2050 to provide additionalrotational support to the closure knob assembly 2000. As can be seen inFIG. 90, the proximal end 1741 of the proximal closure nut 1740 may beformed with a proximally extending tapered hub portion 1746 that isadapted to be nonrotatably received in the axial passage 2054 in the caphub portion 2050. The tapered hub portion 1746 may also be formed with akey or spline arrangement to non-rotatably affix the hub portion 1746with the cap hub portion 2050. Other fastener arrangements and methodsmay be employed to non-movably attach the hub portion 1746 of theproximal closure nut 1740 to the cap hub portion 2050. Thus, rotation ofthe cap hub portion 2050 will cause the proximal closure nut 1740 anddistal closure nut 1720 to also rotate in the manners described aboveand axially advance the adjustment shaft 1650 distally or proximallydepending upon the direction in which the proximal and distal closurenuts are rotated.

Rotation of the proximal and distal closure nuts 1740, 1720 is attainedby rotating the proximal cap portion 2010 relative to the distal capportion 2040. The interaction between the proximal cap portion 2010 andthe distal cap portion 2040 may be controlled by a variable forcegenerating member 2060 that interconnects those components and serves toapply a resistive force to the proximal cap portion 2010 in relation tothe amount of compression experienced by the tissue compressed betweenthe anvil 1700 and the staple cartridge 1616. In various embodiments,for example, the variable force generating member may comprise a spiralspring 2060. In some embodiments, the innermost end 2062 of the spiralspring 2060 may be configured as shown in FIG. 92 and inserted into aretaining slot 2020 in the proximal cap portion 2010. End 2062 of spring2060 may also be attached to the proximal cap portion 2010 by otherfastener arrangements. Likewise, the outer end 2064 of the spring 2060may be configured as shown in FIG. 92 and received in a retention slot2045 formed in the distal cap portion 2040. However, the outer end 2064of spring 2060 may be attached to the distal cap portion 2040 by othersuitable fastener arrangements.

In various embodiments, a reference indicator mark 2070 may be providedon the proximal cap portion 2010 such that it aligns with acorresponding initial mark 2072 on the outer wall 2044 of the distal capportion 2040 when the stapler 1600 a is in the unadvanced or neutralposition. See FIGS. 89 and 95. When in that aligned position, the spiralspring 2060 may essentially be unloaded or it may be under a relativelysmall amount of load necessary to retain the proximal cap portion 2010in that starting position. Rotation of the proximal cap portion 2010 inthe clockwise “CW” direction will be transferred to the distal capportion 2040 through the spring 2060 and to the proximal closure nut1740 attached to the distal cap portion 2040. Rotation of the proximalclosure nut 1740 also causes the distal closure nut 1720 to rotate andaxially draw the adjustment shaft in the proximal “PD” direction. Whenthe adjustment shaft 1650 is drawn proximally, is also causes the anvil1700 to move towards the cartridge because it is attached to the trocartip 1644 which is attached to the adjustment shaft 1650 by means of thetop and bottom tension bands 1636, 1638 as was discussed above. As theanvil 1700 moves closer to the staple cartridge 1616 supported in thehead 1610, the tissue 1904, 1908 clamped therebetween begins to compressand resist further travel of the anvil 1700 to the cartridge. See FIG.93. Such resistive compressive force also must be overcome by the springload to enable the anvil 1700 to further compress the tissue 1904, 1908between the anvil 1700 and the cartridge 1616.

In various embodiments, the amount of spring load (“L1”) necessary toattain a minimum amount of tissue compression (“Min”) may be determinedas well as the amount of spring load “(L2”) required to attain a maximumamount of tissue compression (“Max”) may also be determined. Inaddition, the distance “D1” that the proximal cap portion 2010 must berotated from the neutral position to generate spring load L1 and thedistance “D2” that the proximal cap portion 2010 must be rotated togenerate spring load “L2” may be determined. The graph depicted in FIG.94 illustrates an example of a relationship between these parameters.Those of ordinary skill in the art will appreciate that suchrelationships may change depending upon the spring used and variousother factors such as, for example, frictional forces encountered by themoving components of the device.

As can be seen in FIG. 95, a second indicator mark or indicia 2080corresponding to the position of the proximal cap portion 2010 when ithas been rotated to generate the minimum amount of compression force“Min” is provided on the outer wall 2044 of the distal cap portion 2040such that the second indicia 2080 coincides with the reference indicator2070 on the proximal cap portion 2010. Likewise a third indicator markor indicia 2082 may be provided on the outer wall 2044 of the distal capportion 2040 such that the third indicia 2082 coincides with thereference indicator 2070 on the proximal cap portion 2010 when theproximal cap portion 2010 has been rotated to that position whichgenerates the maximum amount of compression force “Max”. See FIG. 95.Those of ordinary skill in the art will recognize that a variety ofdifferent indicia arrangements may be employed without departing fromthe spirit and scope of the present invention. For example, the area2084 on the outer wall 2044 of the distal cap portion 2040 between thesecond indicia member 2080 and the third indicia member 2082 may bepainted or other wise colored green to indicate to the surgeon that ifthe reference indicator 2070 is located in that region and acceptableamount of compression force may be attained.

Thus, in these embodiments, the spring 2060 provides a means forinterrelating the amount of compression experienced by the tissuelocated between the anvil 1700 and the staple cartridge 1616 and thedistance that the proximal cap portion 2010 must be rotated to attainthat amount of compression. Such arrangement permits the use ofreference indicators and indicia on the proximal and distal cap portions2010, 2040 to enable the surgeon to accurately determine when the anvilhas been located in a position that will result in acceptable stapleformation. These reference indicators and indicia can be so oriented toinform the surgeon when the anvil has been moved to a position that willresult in a minimum amount of compression being applied to the tissuewhile still facilitating the formation of sealing staples. Likewise,such reference indicators and indicia may be so oriented to inform thesurgeon that the anvil has been moved to a position that will result ina maximum amount of compression being applied to the tissue while stillfacilitating the formation of sealing staples.

While the present invention has been illustrated by description ofseveral embodiments and while the illustrative embodiments have beendescribed in considerable detail, it is not the intention of theapplicant to restrict or in any way limit the scope of the appendedclaims to such detail. Additional advantages and modifications mayreadily appear to those skilled in the art. For example, while variousmanually operated surgical instruments have been depicted for clarity,it should be appreciated that such devices may also be roboticallymanipulated. In addition, those skilled in the art will appreciate thatthe embodiments, features and improvements disclosed herein may bereadily employed in connection with a variety of other known surgicalcutter/staplers, staplers, etc. that may have application in open,laparoscopic, endoscopic and/or intralumenal surgical procedures. Inparticular, such unique and novel features may be practiced inconnection with linear staplers, cutters, contour cutters, etc. Thus,the scope and protection afforded to the various embodiments disclosedherein should not be limited solely to endocutter-type surgicalstaplers.

While several embodiments of the invention have been described, itshould be apparent, however, that various modifications, alterations andadaptations to those embodiments may occur to persons skilled in the artwith the attainment of some or all of the advantages of the invention.For example, according to various embodiments, a single component may bereplaced by multiple components, and multiple components may be replacedby a single component, to perform a given function or functions. Thisapplication is therefore intended to cover all such modifications,alterations and adaptations without departing from the scope and spiritof the disclosed invention as defined by the appended claims.

The devices disclosed herein can be designed to be disposed of after asingle use, or they can be designed to be used multiple times. In eithercase, however, the device can be reconditioned for reuse after at leastone use. Reconditioning can include an combination of the steps ofdisassembly of the device, followed by cleaning or replacement ofparticular pieces, and subsequent reassembly. In particular, the devicecan be disassembled, and any number of particular pieces or parts of thedevice can be selectively replaced or removed in any combination. Uponcleaning and/or replacement of particular parts, the device can bereassembled for subsequent use either at a reconditioning facility, orby a surgical team immediately prior to a surgical procedure. Those ofordinary skill in the art will appreciate that the reconditioning of adevice can utilize a variety of different techniques for disassembly,cleaning/replacement, and reassembly. Use of such techniques, and theresulting reconditioned device, are all within the scope of the presentapplication.

Preferably, the invention described herein will be processed beforesurgery. First a new or used instrument is obtained and, if necessary,cleaned. The instrument can then be sterilized. In one sterilizationtechnique, the instrument is placed in a closed and sealed container,such as a plastic or TYVEK® bag. The container and instrument are thenplaced in a field of radiation that can penetrate the container, such asgamma radiation, x-rays, or higher energy electrons. The radiation killsbacteria on the instrument and in the container. The sterilizedinstrument can then be stored in the sterile container. The sealedcontainer keeps the instrument sterile until it is opened in the medicalfacility.

As used herein, the term “fluidically coupled” means that the elementsare coupled together with an appropriate line or other means to permitthe passage of pressurized gas therebetween. As used herein, the term“line” as used in “supply line” or “return line” refers to anappropriate passage formed from rigid or flexible conduit, pipe, tubing,etc. for transporting fluid from one component to another.

Any patent, publication, or other disclosure material, in whole or inpart, that is said to be incorporated by reference herein isincorporated herein only to the extent that the incorporated materialsdoes not conflict with existing definitions, statements, or otherdisclosure material set forth in this disclosure. As such, and to theextent necessary, the disclosure as explicitly set forth hereinsupersedes any conflicting material incorporated herein by reference.Any material, or portion thereof, that is said to be incorporated byreference herein, but which conflicts with existing definitions,statements, or other disclosure material set forth herein will only beincorporated to the extent that no conflict arises between thatincorporated material and the existing disclosure material.

The invention which is intended to be protected is not to be construedas limited to the particular embodiments disclosed. The embodiments aretherefore to be regarded as illustrative rather than restrictive.Variations and changes may be made by others without departing from thespirit of the present invention. Accordingly, it is expressly intendedthat all such equivalents, variations and changes which fall within thespirit and scope of the present invention as defined in the claims beembraced thereby.

As known in the art, surgical staples can be used to hold several layersof tissue together after the tissue has been resected, for example.Often, as described above, a surgical stapler is used to deform thestaples from an undeployed shape into a deployed, i.e., deformed, shape.Referring to FIG. 27, the staples, such as staples 83, for example,include a base, or crown, and deformable legs extending therefrom. Inuse, the deformable legs are typically deformed toward the crown by ananvil in the surgical stapler. Referring to FIG. 27, the amount of thisdeformation is usually dependent upon the thickness of the tissue beingstapled. More particularly, if the tissue is thinner, the anvil isbrought closer to the staple cartridge before the anvil contacts thetissue and, as a result, the staples will have less distance to bedeployed before they are deformed against the anvil. For example, thelegs of the staple on the left in FIG. 27 are inserted through thinnertissue while the legs of the staple on the right are inserted throughthicker tissue and, as a result, the legs of the staple on the left aredeformed more than the legs of the staple on the right. As a result ofthe foregoing, a common staple design can be readily adapted to varioustissues having different thicknesses.

As described above, referring to FIG. 27, the legs of staples 83 arebent toward the base, or crown, of the staple. More particularly, theends of the legs are curled by the anvil of the stapler until thedesired deformation is achieved. Stated another way, when the ends ofthe legs contact the anvil of the stapler, the ends are guided by theanvil such that the legs are continuously bent into an arcuateconfiguration until the staple is deformed into a “B” shape, forexample. In embodiments where the staple has long legs, and/orembodiments where the staples are used in very thin tissue, the legs maybe curled significantly such that their ends project outwardly from thestaple. In these embodiments, the ends may be sharp and may impinge onsurrounding tissue causing discomfort to the patient. To ameliorate thisproblem, the present invention includes staple 1300 which can be bent insegments, as opposed to a continuous arcuate shape as described above.

Similar to the above, referring to FIG. 96, staple 1300 includes crown1302 and deformable legs 1304 and 1306 extending therefrom. Legs 1304and 1306 include first notches 1310, second notches 1312, and thirdnotches 1313 therein. In use, referring to FIG. 105, when ends 1308 oflegs 1304 and 1306 contact pockets 1314 of anvil 1316, ends 1308 can beguided toward each other, for example. As the staple is further driventoward anvil 1316 by sled driver 78, referring to staple 1300 b, legs1304 and 1306 may bend significantly at first notches 1310. Referring toFIG. 97, owing to the reduced cross-section of legs 1304 and 1306 atfirst notches 1310, legs 1304 and 1306 are more susceptible todeformation at this location. For example, when legs 1304 and 1306 arebent at notches 1310, first segments 1318 may bend at an approximately90 degree angle, for example, with respect to second segments 1320 oflegs 1304 and 1306. In other embodiments, first segments 1318 may bebent at any suitable angle with respect to second segments 1320.

Further to the above, referring to FIG. 98, second notches 1312 in legs1304 and 1306 permit second segments 1320 to bend with respect to thirdsegments 1322 at an approximately 90 degree angle, for example. In otherembodiments, second segments 1320 may be bent at any other suitableangle with respect to third segments 1322. Similar to the above, notches1313 permit third segments 1322 to bend with respect to fourth segments1325. As a result of notches 1310, 1312, and 1313, legs 1304 and 1306may not be bent into a continuous curl as described above; rather, theycan be bent into a segmented, rectangular configuration. As a result ofthe above, staples having long legs 1304 and 1306 may be deformed in amanner such that the ends of the deformable members do not extendoutwardly from the staple, rather, they can be positioned intermediatelegs 1304 and 1306 as illustrated in FIG. 99. While the legs of theillustrated staples in FIGS. 96-105 have three notches and foursegments, various embodiments are envisioned which have additional, orless, notches and segments. Furthermore, while the segments of thestaple legs described above are substantially straight, variousembodiments are envisioned in which the segments are curved,curvilinear, or other otherwise suitably configured to achieve a desiredshape.

To facilitate the bending of third segments 1322 with respect to fourthsegments 1325, for example, crown 1302 may include a forming surface, oranvil, for guiding and/or deforming legs 1304 and 1306 when they contactcrown 1302. More particularly, referring to FIGS. 99 and 101-104, aslegs 1304 and 1306 are being deformed from the shape illustrated in FIG.98 to the shape illustrated in FIG. 99, ends 1308 of deformable members1304 and 1306 may contact crown 1302. To guide ends 1308, anvil 1323 ofcrown 1302 includes recesses 1324 which can direct ends 1308 to moveoutwardly as illustrated in FIG. 99 or in any other suitable direction.In various embodiments, recesses 1324 may not deform legs 1304 and 1306significantly, however, in the illustrated embodiment, recesses 1324 areconfigured to deform legs 1304 and 1306 at an approximately 90 degreeangle. In various embodiments, anvil 1316 of the stapler and anvil 1323in crown 1302 can co-operate to deform staple 1300 into the shapeillustrated in FIG. 99, for example, or any other suitable shape.

In various embodiments, although not illustrated, a forming surface, oranvil, can be included in staple cartridge 1326 in addition to, or inlieu of, anvil 1323 in crown 1302. In these embodiments, anvil 1316deforms legs 1304 and 1306 such that ends 1308 contact the recesses instapler cartridge 1326. Similar to the above, the staple cartridgerecesses can be configured to guide and/or deform legs 1304 and 1306when they contact stapler cartridge 1326. In various embodiments, anvilson both crown 1302 and stapler cartridge 1326 can be utilized to deformand/or guide the staple. In the illustrated embodiment, crown 1302includes material 1303 overmolded onto base 1301. As discussed ingreater detail below, material 1303 can be comprised of a plasticmaterial, for example, a bioabsorbable material, and/or anon-bioabsorbable material. In at least one of these embodiments, thematerial 1303 is formed around a single continuous wire comprising base1301 and deformable members 1304 and 1306. In other embodiments,deformable members 1304 and 1306 can include separate deformable membersembedded in plastic material 1303. Further, in various embodiments, thewire comprising base 1301 can be deformed to provide the recesses andanvils described above.

Referring to FIGS. 106 and 107, similar to the above, the staple, invarious embodiments, can include several necked down sections in thestaple legs which can be configured to cause the staple legs to deformand/or buckle at the necked down sections. More specifically, staple1340 can include several necked-down or tapered sections 1342 whichallow staple legs 1344 to deform in segments as described above. Taperedsections 1342, similar to notches 1310, 1312, and 1313, provide a stressconcentration area. Stress concentration areas are typically locationsin which a loaded member, for example, will fail. Stated another way,stress concentration areas may magnify the stress in a particular areaof a loaded member causing the loaded member to yield, or plasticallystrain, at the stress concentration area before the remainder of theloaded member plastically strains. As used herein, the term “yield”generally refers to the point of maximum stress and/or strain abovewhich a material will no longer behave in a completely elastic manner.However, various embodiments are envisioned in which the materials usedherein do not have a traditional yield point, for example. Thesematerials can include materials which strain plastically as soon as theyare stressed and/or super-elastic materials which do not have adiscernable yield point. These materials can include shape memoryalloys, such as Nitinol, for example, that allow for large straindeformations during the above-described forming processes. Typically,engineers are charged with eliminating stress concentration areas toachieve a desired goal; however, according to the teachings of thepresent invention, stress concentration areas can be utilized to achievethe above-described goals.

In various embodiments, referring to FIGS. 108-110, staple 1329 includesbase portion 1331 and two deformable legs 1333 extending therefrom. Legs1333 can each include a first portion 1335 having a substantially roundcross-section and a second portion 1337 having a substantially flatcross-section. In at least one embodiment, legs 1333 and base 1331 arecomprised of a metal wire that is coined, or formed, on its ends tocreate substantially flat portions 1337. As known in the art, coining,or forming, a metal wire may be performed with a stamping press beforeand/or after, the wire is bent into the “U” shape illustrated in FIG.108. Referring to FIG. 110, legs 1333 are configured such that flatportions 1337 can be bent to secure tissue within the staple while roundportions 1335 can remain substantially unbent. In use, as a result,staple 1329 can be used to secure thicker tissues. More specifically,owing to substantially unbent portions 1335, thicker tissues can beaccommodated between portions 1335 while flat portions 1337 can be bentto retain the tissue therebetween. The amount in which flat portions1337 are deformed is typically dependent upon the thickness of thetissue captured in the staple.

In various embodiments, referring to FIG. 111, staple 1441 can includedeformable legs 1443 which have a tapered configuration. Moreparticularly, staple legs 1443 can include a base portion 1444 that hasa larger cross-section than the cross-section of tip portion 1445. Inuse, similar to the above, staple 1441 can accommodate thicker tissuesas, owing to the thicker cross-section of base portions 1444, baseportions 1444 may remain substantially unbent while tip portions 1445are bent to retain the tissue in the staple. In other variousembodiments, referring to FIG. 112, staple 1446 can include severalstepped portions 1447 and 1448 which allow some portions of legs 1449 tobe bent, some portions to be only partially bent, and other portions toremain substantially unbent. The suitable amount and configurations ofthe stepped portions may be selected to accommodate the type and/orthickness of the tissue being secured.

Referring to FIGS. 113 and 114, staple 1350, similar to staple 1340,includes crown 1302 and deformable legs 1344. Staple 1340, as describedabove, in at least one embodiment, is configured to compress tissuebetween deformable legs 1344 and crown 1302. However, in applications inwhich the tissue is very thin, for example, sufficient compression ofthe tissue between deformable legs 1344 and crown 1302 may be difficultto achieve and a gap between the tissue and legs 1344, for example, mayexist. For these applications, it may be desirable to include anadditional member intermediate the tissue and the deformable membersand/or crown which not only fills the gap, but compresses the tissueagainst at least one of the crown and/or deformable members.

Staple 1350, referring to FIGS. 113 and 114, can include, in variousembodiments, deformable, or compressible, member 1352. As describedabove, referring to FIG. 114, compressible member 1352 can bias tissue1353 against deformable legs 1344. As a result of this compression, thelumens, or vessels, in tissue 1353 can be compressed and thereby slowthe flow of blood therethrough. In at least one embodiment, compressiblemember 1352 is entirely elastic after it has been compressed, i.e., theaddition of, or the removal of, any stress onto compressible member 1352will result in a linearly corresponding increase, or decrease, in strainthereof. Stated in another way, in these elastic embodiments,compressible member 1352 can substantially act like a spring. However,in at least one embodiment, compressible member 1352 can be crushable,i.e., after it has been compressed, at least a portion, if not all, ofcompressible member 1352 is permanently deformed and the addition of, orremoval of, any stress onto compressible member 1352 does notnecessarily result in a linearly corresponding strain. In variousembodiments, compressible member 1352 can be comprised of foam. The foamcan be absorbable or non-absorbable. The foam can be comprised ofsynthetic materials and/or mammalian-derived materials including, butnot limited to, polyglycolide trimethylene carbonate copolymer,polyglycolic acid, caprolactone/glycolide, EPTFE, and bovinepericardium. Further, in at least one embodiment, compressible member1352 may include a first portion which is elastically deformable and asecond portion which is plastically deformable.

Referring to FIGS. 115 and 116, staple 1360 can include collapsiblespring member 1362. Collapsible spring member 1362 can include aplurality of first elastic members 1363 and second elastic members 1364.Each first elastic member 1363 can include an arcuate profile whichincludes projections 1365 extending therefrom which are sized andconfigured to contact corresponding projections 1366 extending from eachsecond elastic member 1364. More specifically, first elastic members1363 and second elastic members 1364 are configured such that they canbe stacked upon each other and, when a compressive load is applied tosuch a stack, the first and elastic members can flatten and thereby“collapse” the stack of elastic members. In the illustrated embodiment,collapsible spring member 1362 further includes fasteners 1367 and 1368.Referring to FIG. 115, fasteners 1367 can connect the central portionsof adjacent first elastic members 1363 and second elastic members 1364to prevent the elastic members from becoming dislodged or misalignedwith respect to each other. Similarly, fastener 1368 can preventcollapsible spring member 1362 from becoming dislodged with respect tocrown 1302. In use, collapsible spring member 1362 can provide acompressive load to tissue in between said deformable members and saidcrown.

Referring to FIGS. 117 and 118, staple 1370 can include cantileverspring 1372. Cantilever spring 1372 includes first end 1373 attached tocrown 1302 and second end 1374 which is free to move with respect tofirst end 1373. In use, when tissue is compressed between spring 1372and deformable legs 1344, spring 1372 can apply an upwardly-directedbiasing, or compressive, force against the tissue. More particularly, asdeformable legs 1344 are deformed and pushed against the tissue, secondend 1374 of spring 1372 can move downwardly with respect to first end1373. As a result of this deflection, spring member 1372 storespotential energy and acts to release this potential energy by applyingan upward force against the tissue, thereby compressing the tissuebetween spring member 1372 and deformable legs 1344. In an alternativeembodiment, referring to FIGS. 119-121, spring member 1382 of staple1380 can have first and second ends, 1382 and 1384, respectively,attached to crown 1302. In at least one embodiment, springs 1372 and1382, for example, can be integrally molded with crown 1302. In theseembodiments, springs 1372 and 1382 can be comprised of a dissolvable,bioabsorbable, or biofragmentable material such that, as the materialdissolves, the biasing force of springs 1372 and 1382 can decreasethroughout the healing process. As a result, a larger compressive forcecan be applied during the initial healing stages when the restriction ofblood loss is important and a smaller compressive force can be appliedduring the later healing stages when tissue regeneration is importantwherein the smaller force permits expansion and growth of the tissuewithin the staple.

In other various embodiments, although not illustrated, the tissue canbe positioned, and compressed between, the compressible member and thecrown of the staple. In these embodiments, the deformable members aredeformed against the compressible member which, as a result, iscompressed between the deformable legs and the tissue.

Referring to FIGS. 122 and 123, staple 1400 includes crown 1402, firstdeformable member 1404, and second deformable member 1406. Deformablemembers 1404 and 1406 each include a base 1408, a deformable leg 1410,and a second leg 1412 which, in the illustrated embodiment, arecomprised of a single continuous wire. In other various embodiments,staples 1400 may be configured in any other suitable manner to achievethe goals of the invention described herein. In the illustratedembodiment, members 1404 and 1406 are connected together by a materialthat is overmolded onto the bases 1408 of members 1404 and 1406. Invarious embodiments, the material can include a dissolvable,bioabsorbable, or biofragmentable material such as Vicryl and PDS fromEthicon, Inc., for example. As used herein, the terms dissolvable,bioabsorbable, and biofragmentable all generally refer to materials thatcan be at least partially assimilated by the body after being implantedinto a patient, for example.

In use, staple 1400 can be inserted into the soft tissue of a person,for example, via a stapler and can be deformed into the configurationillustrated in FIG. 124. More particularly, in the illustratedembodiment, deformable members 1404 and 1406 can be deformed by theanvil of the stapler such that ends 1411 of legs 1410 are brought intoclose proximity to crown 1402. Once staple 1400 is implanted into thetissue, crown 1402 may begin to break down, dissolve and weaken. Moreparticularly, referring to FIG. 125, the bioabsorbable material of crown1402 may deteriorate to the point where first member 1404 and seconddeformable member 1406 become disconnected from each other asillustrated in FIG. 126. Once first member 1404 and second member 1406have become disconnected, they can move relative to one another. Thetime required for crown 1402 to sufficiently dissolve may depend on thematerial used and/or the size of crown 1402. Polyglatin 910 material,sold under the tradename Vicryl, for example, may dissolve in 7-14 days.

In various embodiments, dissolvable crown 1402 may provide severaltherapeutic advantages. For example, when staple 1400 is initiallydeployed, deformable members 1404 and 1406 may significantly compressthe tissue within the staple against crown 1402. In some applications,this compression may be desirable to limit bleeding from the tissue. Ascrown 1402 deteriorates, the gap between the deformed members 1404 and1406 and crown 1402 may increase thereby relaxing the compressive forcesacting on the tissue. In some applications, relaxing the compressionforces during the healing process may allow the tissue to slowly expandand return to its normal thickness over a period of time. In someembodiments, crown 1402 can be coated with a hydrophilic material thatinitially expands to compress the tissue captured within the staplebefore dissolving away thereafter. In these embodiments, the hydrophilicmaterial expands by absorbing water from the surrounding tissue andfluids. In addition to the above, staple 1400, when it is inserted intothe tissue, may be very stiff and, if several staples are inserted intothe tissue, the tissue may not be permitted to move and expand duringthe healing process. However, after crowns 1402 of staples 1400 havedissolved, the deformable members 1404 and 1406 of the staples may beable to move relative to each other while still holding the underlyingtissue together.

In various embodiments, deformable members 1404 and 1406 may becomprised of a substantially non-dissolvable or non-bioabsorbablematerial. In other embodiments, at least one of deformable members 1404and 1406 may be comprised of a dissolvable, bioabsorbable, orbiofragmentable material such as magnesium or iron, for example. In atleast one embodiment, the iron is pure iron. In either event, thedissolvable material of members 1404 and 1406 can be selected such thatthey dissolve at the same rate as, slower than, or faster than thedissolvable material of crown 1402. For example, the material of crown1402 can be selected such that it completely dissolves away whiledeformable members 1404 and 1406 are still holding tissue together.Further, in various embodiments, the material of first deformable member1404 can be selected such that it dissolves faster than the material ofsecond deformable member 1406. Accordingly, the deformable members ofthese embodiments may allow for a staggered release of the tissue.Further, in various embodiments, at least two adjacent staples 1400, asdescribed in greater detail below, can be connected by a bridge beforeand/or after the staples have been deployed into the tissue. In theseembodiments, a first staple can be comprised of bioabsorbable materialsthat dissolve away at a faster rate than the materials of a secondstaple attached thereto. Similarly, the bridge connecting the staplescan be comprised of materials that dissolve away at the same rate,and/or a different rate, than the first and second staples. In theseembodiments, the first staples can dissolve away before the secondstaples allowing for a staggered release of the tissue.

The staples described above can be used to approximate tissue, i.e., thestaples can secure resected or damaged tissue such that the strength ofthe resected or damaged tissue approximates that of healthy tissue. Tothis end, a method of approximating tissue can include suturing tissuewith a surgical staple comprised of a dissolvable material and anon-dissolvable material to approximate tissue in a first state, anddissolving the dissolvable material to cause the remainingnon-dissolvable material to approximate the tissue in a second state. Inat least one embodiment, the tissue approximation in the second state ismore flexible than in the first state.

In addition to the above, referring to FIG. 132, crown 1402 may becomprised of at least two overmolded or co-molded materials. Moreparticularly, crown 1402 may be comprised of a first material 1435overmolded onto deformable members 1404 and 1406 and a second material1436 overmolded onto second material 1436, for example. In thisembodiment, second material 1436 can be configured to dissolve awayquickly thereby allowing deformable members 1404 and 1406 to separatefrom each other early on in the healing process. However, first material1435 can be selected to dissolve at a slower rate than second material1436 in order for crown 1302 to continue to provide a compressive forceon the tissue even after second material 1436 has completely dissolvedaway. In at least one embodiment, first material 1435 can be injectionmolded onto deformable members 1404 and 1406 and then permitted to cure,and/or substantially solidify, before second material 1436 is injectionmolded onto first material 1435. In other various embodiments, firstmaterial 1435 and second material 1436 can be injection molded ontodeformable members 1404 and 1406 at substantially the same time or inrapid succession. In these embodiments, the first and second materialscan chemically bond together to provide sufficient strength therebetweenso that the staple may be handled without the first and second materialsseparating from one another. In other embodiments, the first and secondmaterials can form mechanically interlocking features to accomplish thesame result.

In the embodiment illustrated in FIG. 123, crown 1402 may includereduced cross-section 1414 intermediate portions 1416 and 1418. In use,intermediate section 1414, as it has a smaller cross-section thanportions 1416 and 1418, may completely dissolve away before sections1416 and 1418 thereby allowing first member 1404 to become unconnectedfrom second member 1406 before the entirety of crown 1402 has dissolved(FIG. 125). In at least one embodiment, the cross-sections of sections1414, 1416, and 1418 can be selected such that deformable members 1404and 1406 become unconnected at a desired stage in the healing process.In at least one embodiment, referring to FIG. 133, crown 1402 caninclude score marks 1437 which reduce the thickness of crown 1402 in thescored areas. In these embodiments, the score marks may be formed whencrowns 1402 are overmolded onto deformable members 1404 and 1406 orformed by a cutting tool thereafter. As a result of score marks 1437,crown 1402, as it dissolves, can break up into several small pieceswhich are, in some circumstances, more easily absorbable by the body. Inat least one embodiment, referring to FIG. 134, crown 1402 may include aplurality of pockets 1438 intermediate raised portions 1439. In use, thematerial intermediate raised portions 1439 may dissolve away leavingbehind a lattice, or grid, of raised portions 1439 intermediatedeformable members 1404 and 1406.

In at least one embodiment, crown 1402 is also comprised of at least onetherapeutic drug. In these embodiments, as the dissolvable materialdeteriorates, the therapeutic drug can be absorbed by the surroundingtissue. In some embodiments, the drug is dispersed throughout thedissolvable material such that the drug is steadily released during thehealing process, however, in other embodiments, the therapeutic drug maybe unevenly dispersed throughout the dissolvable material, or layeredwithin and/or on the material to provide an increased dosage of the drugat a particular stage in the healing process.

In at least one embodiment, having an absorbable staple with anabsorbable insulator reduces the possibility of arcing along a row ofstaples when an electrocautery device is used in situ, for example. Theabsorbable insulators, or crowns, on the staples substantially preventan electrical current from jumping betweens staples as the top of eachstaple is not electrically conductive under normal operating conditions.As a result, the possibility of damaging tissue is reduced.

In use, as described above, and referring to FIGS. 127 and 128,deformable members 1404 and 1406 of staple 1400 are deformed by anvil1420 of stapler 1422. More particularly, ends 1411 of members 1404 and1406 are received within recesses 1424 in anvil 1420 and are guidedtoward crown 1402 as members 1404 and 1406 are deformed by anvil 1420.Referring to FIGS. 129 and 129A, recesses 1424 can include aconfiguration which causes the ends of members 1404 and 1406 to bend outof plane with members 1412 and bases 1408. More particularly, referringto FIGS. 130 and 131, each recess 1424 includes several planar surfacesoriented to initially deflect end 1411 laterally, and then downwardly,to curl the top portion of deformable leg 1410 alongside the bottomportion of deformable leg 1410 as illustrated in FIG. 131. Referring toFIGS. 130 and 131, recess 1424 includes surfaces 1426 and 1428 whichform vertex 1430 therebetween. Surfaces 1426 and 1428, and vertex 1430,are configured to receive end 1411 of deformable member 1406, forexample. After sufficient pressure is applied by anvil 1420, leg 1410 ofdeformable member 1406 is curled within vertex 1430. Thereafter, as leg1410 is further deformed, leg 1410 also contacts vertex 1432 which isintermediate surfaces 1428 and 1434 of recess 1424. As illustrated inFIG. 131, vertex 1432 assists in deforming member 1406 into a desiredshape. While the above anvils are described in connection with staples1400, these anvils can be used to deform other differently-configuredstaples including the suitable staples disclosed in this application.

Referring to FIGS. 96 and 97, staple 1300 includes an integral staplecrown and driver. More particularly, referring to FIG. 105, crown 1302is configured to be directly driven by cam sled 78. In use, as describedin detail above, cam sled 78 is progressed through staple cartridge 1326from the position illustrated in FIG. 105 toward distal end 1327 ofstaple cartridge 1326. As cam sled 78 is moved in this direction,staples 1300 are successively lifted by cam sled 78 toward anvil 1316.In previous surgical staplers, a separate driver was positionedintermediate the cam sled and the staple. However, the present inventionsimplifies these previous systems by including features in crown 1302which allow staples 1300 to be directly lifted by cam sled 78. Moreparticularly, referring to FIGS. 96 and 97, crown 1302 includes beveledsurfaces 1328 which are configured to co-operate with angled surface1330 of cam sled 78 such that crowns 1302 slide up cam surface 1330. Inthe illustrated embodiment, both beveled surfaces 1328 and cam surface1330 are oriented at an approximately 30 degree angle with respect tothe horizontal. As a result, in the present embodiment, beveled surface1328 may sit flushly on cam surface 1330, however, embodiments areenvisioned in which beveled surfaces 1328 and cam surface 1330 are notoriented at the same angle. Furthermore, the present invention is notlimited to embodiments having 30 degree angles. On the contrary, anysuitable angle, or angles, can be used.

Referring to FIGS. 96 and 97, base 1301 of staple 1300, in theillustrated embodiment, is embedded in crown 1302. More particularly,crown 1302 can be overmolded onto base 1301 such that crown 1302 tightlysurrounds base 1301 and wherein, in the present embodiment, base 1301 isenveloped or enclosed by crown 1302. In other various embodiments, crown1302 may be separately manufactured and then assembled to base 1301. Ineither event, base 1301 and/or deformable members 1304 and 1306 can beat least partially embedded into crown-driver 1302. As a result, staple1300 can include larger deformable members 1304 and 1306 than inprevious designs. In these embodiments, as a result of the above, staple1300 may accommodate larger tissues intermediate the deformable membersand tissue-contacting surface 1336 of crown 1302. In one embodiment,crown-driver 1302 may be comprised of a dissolvable or bioabsorbablematerial, as described above, that, as it dissolves, allows the tissuecompressed within staple 1300 to expand and grow. In variousembodiments, as described above, crown-driver 1302 may be comprised of,or coated by, a hydrophilic material that expands when exposed to waterin the body to further compress the tissue in the staple. Further,similar to the above, crown-driver 1302 may be configured to increasethe contact area between crown 1302 and the tissue. In some embodiments,increasing this contact area reduces the localized stress on the tissuesurface which may reduce the possibility of tissue necrosis, forexample.

As indicated above, an integral staple crown and driver may reduce thequantity of components needed to deploy the staples. As a result,embodiments in accordance with the present invention may reduce the costand/or manufacturing time to produce the stapling systems. Further,eliminating the separate driver components may reduce the possibility ofmisalignment between the staples and the cam sled.

In an alternative embodiment of the present invention, referring to FIG.135, staples 1450 can each include a crown 1451 and two deformable legs1452 extending therefrom. Referring to FIG. 135, the crowns of staples1450 can be connected together by bridge 1455. Similar to the above,crowns 1451 and bridge 1455 can be integrally molded onto staple legs1452. Also similar to the above, crowns 1451 can include beveledsurfaces 1453 which, referring to FIG. 139, can be configured tocooperate with angled surface 1454 of cam driver 1462. As above, camdriver 1462 is configured to successively raise staples 1450 toward ananvil positioned opposite deck 1456 of staple cartridge 1457. Asdiscussed in greater detail below, bridges 1455 can be configured toconnect staples 1450 even after they have been deployed or,alternatively, staple cartridge 1457 can include shears which breakbridges 1455 and separate staples 1450 when they are deployed.

Staple cartridge 1457, referring to FIGS. 136-138, further includescavities 1458 configured to receive staples 1450. In at least oneembodiment, cavities 1458 include keys 1459 which are sized andconfigured to fit within slots 1460 in crowns 1451. More particularly,slots 1460 and keys 1459, in the present embodiment, are configured tosubstantially limit the motion of staples 1450 with respect to staplecartridge 1457 to a substantially linear motion, i.e., in the presentembodiment, an upwardly and/or downwardly motion. As a result of thesefeatures, the possibility of staples 1450 becoming bound within ormisaligned with respect to cavities 1458 can be reduced. In alternativeembodiments, cavities 1458 can include slots and staples 1450 can havekeys.

Although surfaces 1453 have been described herein as being beveled,surfaces 1453 are not limited to flat surfaces. On the contrary, variousembodiments are envisioned in which surfaces 1453 are curved, radiused,curvilinear, and/or include several sections having variousconfigurations. In either event, surfaces 1453 are configured toco-operate with cam sled 1462 such that staples 1450 are deployed asdescribed above. Similarly, surface 1454 of cam sled 1462 is not limitedto a flat surface. On the contrary, surface 1454 can be curved,radiused, curvilinear, and/or have any other suitable configuration.

Staple cartridge 1500, referring to FIG. 140, includes recesses 1502 forreceiving staple strips 1504. Referring to FIGS. 140 and 141, staplestrips 1504 include several staples 1506 connected together by bridges1508. Recesses 1502 include several pockets 1510 which are sized andconfigured for receiving staples 1506 therein. In at least oneembodiment, staples 1506 include deformable members 1512 which are sizedand configured to be biased against the sidewalls of notches 1514 inrecesses 1502. More particularly, deformable members 1512 can beconfigured to create a press-fit between staples 1506 and pockets 1510such that staple strips 1504 remain seated within recesses 1502 undernormal usage conditions. However, in the present embodiment, staplestrips 1504 can be removed from recesses 1502 with a moderateapplication of force.

As illustrated in FIG. 140, recesses 1502 open to top surface 1516 ofstaple cartridge 1500 such that staple strips 1504 can be inserted intostaple cartridge 1500 by aligning strips 1504 with recesses 1502 in topsurface 1516 and pressing them into the position illustrated in FIG.141. Referring to FIG. 141, recesses 1502 further include recessportions 1518 intermediate adjacent pockets 1510 which are sized andconfigured for receiving bridges 1508. In the embodiment illustrated inFIGS. 140-143, bridges 1508 are configured such that adjacent staples1506 can move with respect to each other when being inserted intopockets 1510. Accordingly, bridges 1508 can accommodate dimensionaldifferences, and/or manufacturing tolerances, in the alignment of strips1504 with recesses 1502. More particularly, each bridge 1508 can includea curved portion 1520 configured to allow portions 1522 of bridge 1508to move with respect to each other.

In the illustrated embodiments, the deformable members of each staple1506 comprise a single continuous wire that can be bent into a “U”and/or “V” shape. Crowns 1513, in the present embodiment, can beovermolded onto a portion of these wires such that the wires areembedded into and supported by crown 1513. In addition, as illustratedin FIG. 143, bridges 1508 can be integrally molded with crowns 1513 whencrowns 1513 are overmolded onto the wire. As a result, bridges 1508 andcrowns 1513, in the present embodiment, can comprise an integral,continuous body of plastic, for example. Although not illustrated,bridges 1508 and crowns 1513, in various embodiments, may be molded as aseparate component, or components, that are attached to the staples. Inthese embodiments, the wires of the staples can be press-fit and/orglued into recesses in the separately molded components, for example.

In use, referring to FIG. 144, as sled 78 is moved forward, sled 78lifts staples 1506 upwardly toward an anvil positioned opposite topsurface 1516. Owing to the angled orientation of surface 1523 of sled78, staples 1506 a-1506 e, for example, are incrementally lifted insuccessive order. More particularly, staples 1506 a and 1506 b, whilethey are being lifted by sled 78, may be lifted to different relativeheights with respect to surface 1516 at any given moment. To accommodatethis difference in relative position, bridge 1508 a can be flexible suchthat it does not break as staple 1506 a is being deployed. Bridge 1508a, in the embodiment illustrated in FIG. 144, can be configured suchthat it remains attached to staples 1506 a and 1506 b during thedeployment thereof and, in addition, during the initial healing processof the patient.

In other various embodiments, referring to FIGS. 145-147, staples 1506can be connected together by bridges 1526 to form staple strips 1528.Similar to bridges 1508, bridges 1526 can be integrally formed withcrowns 1513 when crowns 1513 are overmolded onto deformable members 1512as described above. However, bridges 1526, unlike bridges 1508, can beconfigured such that they break away from at least one of the twoadjacent staples 1506 that they connect. More particularly, referring toFIGS. 146 and 147, bridges 1526 can include notches 1530 therein whichare configured to reduce the cross-sectional thickness, and strength, ofbridges 1526. In use, referring to FIG. 147, as staple 1506 a is liftedupwardly with respect to staple 1506 b, bridge 1526 a can break awayfrom staple 1506 a. Stated another way, when staple is 1506 a is liftedupwardly, the stress created within bridge 1526 a by pulling staple 1506a away from staple 1506 b may cause bridge 1526 a to break, especiallyin the portion of bridge 1526 a having notch 1530 therein.

In the illustrated embodiment, bridge 1526 a may remain attached tostaple 1506 b after it has been deployed. In other embodiments, bridge1526 a may remain attached to staple 1506 a. In either event, notches1530 can be designed such that bridges 1526 remain attached to a desiredstaple. In other embodiments, bridges 1526 may separate from bothadjacent staples 1506 and fall into a cavity (not illustrated) withinstaple cartridge 1500, and/or sled 78. In these embodiments, theseparated bridges 1526 may be removed from the stapler by removing thestaple cartridge and/or removing them through an access panel in eitherthe staple cartridge and/or the sled. In various embodiments, notches1530 are not included in every bridge 1526. In these embodiments,several staples may remain attached to each other after being deployedwhile other staples may be detached. In these embodiments, the stiffnessof the row of staples, when inserted into the tissue, can be controlledby selectively alternating whether the staples are attached or detached.

Referring to FIG. 146, bridges 1526 may include a substantially flat topsurface 1532 which is substantially flush with top surfaces of crowns1513. Bridges 1526 may further include a substantially arcuate surface,or lobe, 1534 in the bottom of bridges 1526 such that the thickestportions of bridges 1526 are adjacent to staples 1506. As a result ofthis configuration, the overall deflection of staple strip 1528 may bereduced making staple strip 1528 easier to insert into the staplecartridge. In other embodiments, referring to FIGS. 148-150, bridges1536 may have lobes 1534 which face upward, i.e., in the oppositedirection that they face on bridges 1526. In lieu of the configurationsof bridges 1526 and 1536 which have a flat surface 1532, the bridges maycomprise an arcuate configuration on both sides of the bridge. In theseembodiments, similar to the embodiment in FIGS. 142 and 143, the bridgesmay deflect to permit some relative movement between adjacent staples1506.

In various other embodiments, referring to FIGS. 151-157, the staplestrips may be loaded into the staple cartridge from the bottom of thestaple cartridge. For example, referring to FIGS. 155-157, staplecartridge 1550 includes cavities 1552 and 1554 which are sized andconfigured for receiving staple strips 1540 and 1542, respectively. Inuse, staple strips 1540 and 1542 are aligned with openings 1555 and 1557in bottom surface 1551 and are inserted into cavities 1552 and 1554,respectively. In various embodiments, staple strips 1540 and 1542 may beconfigured such that they are press fit into cavities 1552 and 1554. Inthese embodiments, similar to the above, deformable members 1512 couldengage the sidewalls of the cavities to retain staple strips 1540 and1542 in staple cartridge 1550. In various embodiments, crowns 1513and/or bridges 1538 of staple strips 1540 and 1542 can be dimensionedsuch that they engage the sidewalls of cavities 1552 and 1554 in afriction-fit manner. In other embodiments, staple cartridge 1550 andstaple strips 1540 and 1542 may include co-operating detent featureswhich retain the staple strips in the staple cartridge. Once insertedinto the cavities, staples 1541 of staple strips 1540 and 1542 can bepositioned such that a portion of their deformable members 1512 extendthrough openings 1559 and 1561 in top surface 1553. Deformable members1512 of staples 1541, as illustrated in FIG. 151, can extendsubstantially perpendicularly from crowns 1513.

Similar to the above, referring to FIGS. 155 and 156, staple strips 1540and 1542 can be advanced upward through cavities 1552 and 1554 toward ananvil positioned opposite top surface 1553 from a first positionillustrated in FIG. 155 to a second position illustrated in FIG. 156.When staple strips 1540 and 1542 are advanced into the positionillustrated in FIG. 153, bridges 1538 may be pressed against shears 1560of staple cartridge 1550. Thereafter, the staple strips may be pushedfurther upward causing shears 1560 to break bridges 1538 away from oneor more of staples 1541, as described above. Referring to FIG. 154,shears 1560 in cavity 1552 include projections 1562 which extendtherefrom and are configured to break bridges 1538 away from crowns 1531at locations 1564 (FIG. 151).

In any of the embodiments described herein, the material overmolded ontothe staples to form crowns 1513 and bridges 1526, and/or bridges 1508,may be comprised of a dissolvable, bioabsorbable or biofragmentablematerial. Further, similar to the above, in various embodiments, thebioabsorbable material may include at least one therapeutic drug mixedtherein or coated thereon, for example. Similar to the above, in variousembodiments, drivers may be connected to, and/or integrally molded with,the crowns of the staples.

In alternative embodiments, the staples may be connected in “puck”configurations in lieu of strips, for example. In various embodiments,referring to FIG. 158, staple pucks 1571 and 1572 include staples 1506which are interconnected by bridges 1574 and 1575. Staple pucks 1571have five staples 1506 which are interconnected by two bridges 1574 andtwo bridges 1575. As illustrated in FIG. 158, bridges 1575 connectadjacent staples 1506 such that the tops of their crowns 1513 aresubstantially flush with each other, however, bridges 1574 connectadjacent staples 1506 such that the top of their crowns 1513 arevertically offset from each other. Similarly, staple pucks 1572 includefour staples 1506 which are interconnected by two bridges 1574 and twobridges 1575.

Referring to FIGS. 159 and 159A, staple cartridge 1576 includes cavities1577 which are sized and configured for receiving staple pucks 1571, andcavities 1578 which are sized and configured for receiving staple pucks1572. Referring to FIG. 160, staple cartridge 1576 further includesdrivers 1579 and 1580 which are sized and configured for supportingstaple pucks 1571 and 1572, respectively, thereon. More specifically,referring to FIGS. 161-163, drivers 1579 and 1580 can include shears1581 upon which staples pucks 1571 and 1572 are supported. After beinginserted into cavities 1577 and 1578, referring to FIG. 163, bridges1574 and 1575 are positioned over shears 1581. In use, as describedabove, drivers 1579 and 1580 are lifted toward deck 1582 of staplecartridge 1576 by a cam sled. However, referring to FIG. 163, oncedrivers 1579 and 1580 contact bridges 1574 and 1575, and the upwardmovement of staple pucks 1571 and 1572 is prohibited by staple cartridge1576, further upward movement of drivers 1579 and 1580 causes shears1581 to break bridges 1574 and 1575, thereby separating staples 1306.Once bridges 1574 and 1575 have been broken, support surfaces 1582 ofdrivers 1579 and 1580 are configured to push staples 1306 upwardlytoward an anvil, as described above. Referring to FIGS. 164 and 164A, analternative staple cartridge 1583 is illustrated having recesses sizedand configured for receiving alternate configurations of the staplepucks.

In at least one alternative embodiment of the present invention,referring to FIGS. 165 and 166, staple pucks 1584 and 1585 can beconfigured such that bridges 1586 interconnecting staples 1587, forexample, include shears 1588 extending therefrom. In the presentembodiment, referring to FIG. 167, shears 1588 can be configured todissect deck 1589 of staple cartridge 1590. More particularly, as staplepucks 1585 are raised by cam sled 1591, for example, shears 1588 canbreak through deck 1589 such that pucks 1585 can be raised above deck1589 when deployed. As a result, staples 1587 can be completely deployedfrom staple cartridge 1590 before staple cartridge 1590 is removed fromthe surgical site. In alternative embodiments, although not illustrated,the staple cartridge can also include shears which detach staples 1587from bridges 1586, and/or shears 1588, after shears 1588 have dissectedstaple cartridge deck 1589. Similar to the above, bridges 1589 caninclude beveled surfaces 1592 which are configured to co-operate withcam sled 1591.

Referring to FIG. 168, staples 1465 can each include a first deformableleg 1466, a second deformable leg 1467, and a base 1468 connectingdeformable legs 1466 and 1467. Unlike previous staples which have a basethat is substantially co-planar with its legs, base 1468 can extend inat least one direction that is transverse to a plane defined by legs1466 and 1467. More particularly, base 1468 can include first portion1469 and second portion 1470 which extend laterally from legs 1466 and1467 and form an angle therebetween. In the present embodiment,referring to FIG. 169, first portion 1469 forms an approximately 90degree angle with respect to second portion 1470. However, the presentinvention is not limited to 90 degree angles; rather, any suitable anglemay be used. More particularly, the angle between first portion 1469 andsecond portion 1470 may, in some embodiments, be greater than 90 degreesand may, in other embodiments, be less than 90 degrees. Furthermore, inother embodiments, base 1468 may include several substantially linearsegments and/or curved sections.

Staple 1465 can further include crown 1471 overmolded onto base 1468.More particularly, owing to the configuration of base 1468 as describedabove, crown 1471 can also extend transversely with respect to the planedefined between legs 1466 and 1467. Referring to FIGS. 168 and 169,crown 1471 can include tissue-contacting surface 1472 which is sized andconfigured for supporting tissue thereon. Tissue-contacting surface1472, owing to the configuration of crown 1471, can be larger than thetissue contacting surfaces of previous staples. Accordingly, the largercontact surface can reduce the localized pressure acting on the tissuecaptured within the staple. As known in the art, reducing this localizedpressure can reduce the possibility of tissue necrosis without reducingthe compressive force acting on the tissue. Stated another way, thepressure acting on the tissue is a function of the force acting on thetissue divided by the area in which it acts. Increasing the area canreduce the localized pressure while not reducing the clamping forceapplied by the staple.

Further, owing to the configurations of base 1468 and crown 1471, thelarger surface area of crown 1471 can improve the stability of crown1471, and the surrounding tissue, after the staple has been deployedinto the tissue. More particularly, after previous staples are deployed,the relatively-narrow crowns of these previous staples may not preventthe staples from rocking with respect to the tissue or straining thetissue surrounding the staple. Staples 1465, owing to the configurationof crown 1471, can reduce, and possibly eliminate, these previousproblems. More specifically, owing to larger contact surface 1472, crown1471 is more stable, i.e., it is less likely to rotate with respect tothe tissue. Furthermore, the crowns of previous staples, owing to theirnarrower configurations, may cut through the underlying tissue. Staple1465, owing to the larger configuration of crown 1471, may reduce, oreven eliminate, this possibility. In an alternative embodiment,referring to FIG. 173, staple assembly 1479 can include several of the“J” deformable members of staple 1400 (FIGS. 122 and 123).

To further improve the stability of staples 1465, two adjacent staples1465, for example, may be connected together by bridge 1473. Morespecifically, referring to FIGS. 168 and 169, the base 1468, and crown1471, of the first staple may be laterally disposed in one direction andthe base 1468, and crown 1471, of the second staple may be laterallydisposed in the opposite direction. These oppositely disposed featuresmay improve the stability of the staples by providing stabilizingsurfaces on opposite sides of the assembly. The two staples, referringto FIG. 172, may be deployed from staple cartridge 1475 by cam sled 1474at the same time. To facilitate the deployment of the staples, staplecartridge 1475 may include, similar to the above, slots 1476 sized andconfigured for receiving keys 1477 extending from crowns 1471 of staples1465. More particularly, keys 1477 and slots 1476 can be configured tolimit the movement of staples 1465 with respect to staple cartridge 1475to a substantially linear upward motion. In addition, similar to theabove, each bridge 1473 can include an integral driver 1478 which isconfigured to co-operate with cam sled 1474. In at least one embodiment,crowns 1471, bridge 1473 and driver 1478 can be comprised of adissolvable or bioabsorbable material.

As known in the art, staples can be deployed into tissue such thatstaples are aligned in a row. However, in the past, staples configuredin diagonal patterns have been disincentivized owing to potential leakpaths between the staples. The staples of the present invention canovercome these previous problems. Referring to FIGS. 174 and 175,staples 1480 each include two deformable members 1481 extending from acrown 1482 and bridge 1483 connecting crowns 1482. When staples 1480 areinserted into tissue, as described above, the tissue is compressedbetween crowns 1482 and deformable members 1481. However, in theembodiments in which bridges 1483 are inserted into the body along withstaples 1480, bridges 1483 can also compress the tissue and close offany leak paths therebetween. Referring to FIG. 175, staple cartridge1484 includes recesses 1485 therein which are configured to receivestaples 1480 in a diagonal pattern such that staples 1480 can bedeployed into the tissue as described above.

In an alternative embodiment, a portion of the staple cartridge can bebroken away therefrom during the deployment of the staple. This portioncan be configured to be positioned intermediate the base of the stapleand the tissue captured within the staple. More particularly, referringto FIGS. 176-178, a surgical stapling system can include staplecartridge 1486 having staple pads 1487 integrally molded into deck 1488of staple cartridge 1486. Staple cartridge 1486 can include score marks1489 and slots 1490 surrounding staple pads 1487 such that staple pads1487 can be easily separated from deck 1488. More particularly,referring to FIG. 178, the stapling system can include drivers 1491having shears 1492 which are configured to press against staple pads1487 when base 1493 is brought in close proximity to staple saddle 1494and “punch-out” staple pads 1487. In at least one embodiment, after theyhave been punched out, the staple pads can be positioned intermediatebase 1493 and the tissue captured within the staple. As a result, staplepads 1487 can be configured to act as the crown of the staple or, inalternative embodiments, act as a buttressing member intermediate thestaple and the tissue. In at least one embodiment, similar to the above,staple pads 1487 can be comprised of a bioabsorbable material.

The staples described above can be used in various surgical techniques.For example, one surgical technique can include a method of transectingtissue or a hollow organ by positioning a surgical stapling systemadjacent tissues to be transected, the surgical stapling systemincluding at least one of the staples described above, actuating thesurgical stapling system to compress the tissues together, actuating thesurgical stapling system to fasten and divide the tissue with saidstaple, and removing the surgical stapling system from the operativesite. In at least one embodiment, the surgical technique can include theanastomosis of two hollow organs and/or the fixation of at least twotissues.

1. A surgical staple, comprising: a first deformable member; a seconddeformable member; and a base connecting said first deformable memberand said second deformable member, said base having a first portion anda second portion, said first portion extending transversely to saidsecond portion.
 2. The surgical staple of claim 1, wherein said base iscomprised of a wire, and wherein said first portion and said secondportion define portions of said wire.
 3. The surgical staple of claim 1,wherein said staple further includes a crown attached to said base. 4.The surgical staple of claim 3, wherein said crown is overmolded ontosaid base.
 5. The surgical staple of claim 3, wherein said crown isconnected to a crown of a second staple, said second staple furtherincluding: a first deformable member; a second deformable member; and abase connecting said first deformable member and said second deformablemember, said base having a first portion and a second portion, saidfirst portion extending transversely to said second portion.
 6. Thesurgical staple of claim 3, wherein said crown is comprised of abioabsorbable material.
 7. The surgical staple of claim 3, wherein saidcrown includes a tissue-contacting surface, and wherein said firstdeformable member and said second deformable member are configured tocapture tissue intermediate said tissue-contacting surface and saidfirst and second deformable members.
 8. The surgical staple of claim 3,wherein said staple further includes a driver attached to said crown,said driver having a cam-contacting surface configured to operativelyengage with a cam of a stapler.
 9. The surgical staple of claim 1,wherein said first portion extends at an approximately 90 degree angleto said second portion.
 10. A surgical staple, comprising: a firstdeformable member; a second deformable member, said first member andsaid second member defining a plane; and a base, wherein said firstmember, said second member, and said base are comprised of a wire, andwherein at least a portion of said base extends transversely to saidplane.
 11. The surgical staple of claim 10, wherein said staple furtherincludes a crown attached to said base.
 12. The surgical staple of claim11, wherein said crown is overmolded onto said base.
 13. The surgicalstaple of claim 11, wherein said crown is connected to a crown of asecond staple, said second staple further including: a first deformablemember; a second deformable member; and a base connecting said firstdeformable member and said second deformable member, said base having afirst portion and a second portion, said first portion extendingtransversely to said second portion.
 14. The surgical staple of claim11, wherein said crown is comprised of a bioabsorbable material.
 15. Thesurgical staple of claim 11, wherein said crown includes atissue-contacting surface, and wherein said first deformable member andsaid second deformable member are configured to capture tissueintermediate said tissue-contacting surface and said first and seconddeformable members.
 16. The surgical staple of claim 11, wherein saidstaple further includes a driver attached to said crown, said driverhaving a cam-contacting surface configured to operatively engage with acam of a stapler.
 17. The surgical staple of claim 10, wherein said baseincludes a first portion and a second portion, and wherein said firstportion extends at an approximately 90 degree angle to said secondportion.
 18. A surgical staple assembly, comprising: a first staplehaving a first leg and a second leg; a second staple having a first legand a second leg, said first leg of said first staple and said first legof said second staple defining a plane therebetween, wherein said secondleg of said first staple is offset from said plane; and a crownconnecting said first staple and said second staple.
 19. The surgicalstaple assembly of claim 18, wherein said crown includes atissue-contacting surface configured to apply a compressive forceagainst tissue when said first staple and said second staple have beendeployed into said tissue.
 20. The surgical staple assembly of claim 18,wherein said second leg of said second staple is offset from said plane.21. A surgical stapling assembly, comprising: a first staple having afirst leg and a second leg; a second staple having a first leg and asecond leg; and a staple cartridge having a first cavity configured forreceiving said first staple and a second cavity configured for receivingsaid second staple, said staple cartridge having a proximal end and adistal end, wherein said first cavity is configured such that said firstleg of said first staple is positioned distal with respect to saidsecond leg of said first staple when said first staple is positioned insaid first cavity, and wherein said second cavity is configured suchthat said first leg of said second staple is positioned distal withrespect to said second leg when said second staple is positioned in saidsecond cavity.
 22. The surgical stapling system of claim 21, whereinsaid first leg of said first staple is positioned distal with respect tosaid first leg of said second staple when said first staple ispositioned in said first cavity and said second staple is positioned insaid second cavity.
 23. The surgical stapling system of claim 21,wherein said first staple is connected to said second staple such thatsaid first leg and said second leg of said first staple are co-planarwith a plane defined between said first leg and said second leg of saidsecond staple.